Peptide Therapy and the Lower Extremity: What Every Podiatrist Should Know

This review covers commonly encountered peptide therapies and examines potential implications for lower extremity care, with particular emphasis on adverse effects and practical considerations relevant to podiatrists.

Key Takeaways

• Peptide therapies range from well-established medications, such as GLP-1 receptor agonists and teriparatide, to investigational compounds supported by limited human evidence.
• Commercial availability does not establish a peptide product as an accepted treatment for lower extremity pathology. Clinicians should verify its FDA approval status, approved indication, and supporting clinical evidence.
• When evaluating a patient who uses—or is considering—a peptide therapy, podiatrists should clarify the specific product, dose, route, source, and intended indication rather than treating peptides as a single therapeutic category.
• Peptide therapies should not distract from or replace evidence-based vascular, neurologic, infectious, mechanical, wound, nutritional, and surgical management, which remains the foundation of lower extremity care.

Peptides are short chains of amino acids that participate in numerous physiologic processes, including endocrine signaling, metabolism, cellular communication, tissue remodeling, and bone homeostasis. Several peptide-based medications have become important components of contemporary clinical practice, including GLP-1 receptor agonists, dual incretin therapies, and anabolic bone therapies such as teriparatide.^1-7

More recently, we have seen the term peptide therapy enter the public lexicon through an expanding market of products promoted for weight loss, longevity, athletic recovery, anti-aging, and tissue regeneration. The resulting landscape is highly heterogeneous. A patient receiving semaglutide for obesity is receiving a medication supported by large randomized clinical trials and extensive clinical experience. In contrast, a patient using BPC-157 or a commercially marketed thymosin β4-related product for Achilles tendinopathy may be receiving a therapy supported primarily by preclinical research or limited early human evidence.

This distinction is clinically important for podiatrists. The lower extremity is affected by systemic metabolic, vascular, nutritional, neurologic, and musculoskeletal factors. Patients using peptide therapies may therefore present with clinical questions involving diabetic foot disease, chronic wounds, tendon pathology, fractures, obesity-related mechanical stress, or perioperative management.

In this review, we categorize available evidence using a 5-level hierarchy: Level I, randomized controlled trials, systematic reviews, meta-analyses, or major guidelines; Level II, prospective comparative studies; Level III, observational studies; Level IV, case reports, case series, or pilot studies; and Level V, preclinical or mechanistic evidence. When evidence is inadequate to support a clinical recommendation, we describe it as insufficient.

The Modern Peptide Landscape

Several peptide-based therapies have defined mechanisms of action, standardized pharmaceutical formulations, regulatory approval for specific indications, and extensive clinical trial data. Examples include GLP-1 receptor agonists such as semaglutide, liraglutide, and dulaglutide; dual GIP/GLP-1 receptor agonism with tirzepatide; and parathyroid hormone analog therapy, including teriparatide.^1-7

GLP-1-based therapies are particularly relevant to podiatric practice because of the high prevalence of diabetes and obesity among patients with lower-extremity disease. Large randomized trials have demonstrated clinically meaningful effects on glycemic control, body weight, and cardiovascular outcomes for several GLP-1-based therapies.^1-7

However, the existence of metabolic benefits does not mean that these medications are established therapies for diabetic foot ulcers, tendon injuries, or postoperative wound healing. One must interpret the evidence according to the specific indication being considered.

GLP-1 Receptor Agonists and Dual Incretin Therapy

GLP-1 receptor agonists influence glucose-dependent insulin secretion, glucagon physiology, appetite, and gastrointestinal motility. Tirzepatide activates both GLP and GLP-1 receptors and has demonstrated substantial effects on glycemic control and body weight.^5-7

The clinical significance for podiatric practice is primarily indirect. Improved metabolic health and weight reduction may alter the systemic environment in which lower-extremity disease develops and is treated. Nevertheless, podiatrists should avoid assuming that these medications are established therapies for diabetic foot ulcers, tendon pathology, or postoperative wound healing.

Limited observational research has begun to examine whether GLP-1 receptor agonist use may be associated with improved outcomes among patients with diabetic foot disease. In a retrospective TriNetX database study, semaglutide use was associated with lower rates of several wound-related complications, chronic nonhealing wounds, wound care, wound dehiscence, and amputation among patients with diabetes-related foot ulcers.⁸

A separate nationwide observational study of 133,791 patients with incident diabetic foot ulcers found that GLP-1 receptor agonist use was associated with lower 1-year mortality, including among patients who underwent major amputation.⁹

More recently, a propensity score-matched retrospective cohort study of diabetic patients undergoing soft-tissue reconstruction for foot ulcers found that GLP-1 receptor agonist use was associated with lower rates of surgical-site infection, revision surgery, deep venous thrombosis, emergency department utilization, and all-cause mortality, although no significant differences were observed for wound dehiscence, pulmonary embolism, sepsis, or amputation.¹⁰

These studies remain hypothesis-generating and are vulnerable to residual confounding and other limitations inherent to observational research. Accordingly, current evidence is insufficient to establish GLP-1 receptor agonists as direct wound-healing therapies.

Evidence grade: Level I for metabolic and cardiovascular indications; Level III or lower for direct lower-extremity outcomes.

Adverse Effects Relevant to Lower Extremity Care

Gastrointestinal Symptoms and Volume Depletion. Nausea, vomiting, diarrhea, constipation, and other gastrointestinal symptoms are recognized adverse effects of GLP-1-based therapies. Persistent gastrointestinal symptoms may reduce oral intake and contribute to dehydration. Product labeling also recognizes postmarketing reports of acute kidney injury, including cases associated with gastrointestinal adverse reactions and volume depletion.¹¹

For the podiatrist, this may become relevant when patients have chronic wounds, are undergoing rehabilitation, or are preparing for surgery. A patient with prolonged vomiting, reduced oral intake, or dehydration may have reduced exercise tolerance and difficulty participating in postoperative rehabilitation.

Clinicians should document the following, when reported:

• the specific peptide being used
• recent dose changes
• recent weight loss
• nausea, vomiting, or diarrhea
• reduced oral intake
• weakness or reduced functional capacity.

Persistent or clinically significant symptoms should prompt communication with the prescribing clinician.

Evidence grade: Level I for the adverse-effect profile of established GLP-1 therapies.

Weight Loss, Lean Mass, and Functional Status

Weight loss associated with incretin-based therapies may include reductions in absolute lean mass. However, the clinical significance of this finding requires interpretation in the context of total body composition, physical function, age, nutritional status, and exercise.

Recent systematic reviews and meta-analyses have demonstrated reductions in absolute lean mass during GLP-1-based weight-loss treatment, while lean mass as a proportion of total body weight may increase. A separate meta-analysis comparing incretin-based therapies with lifestyle interventions found that the proportion of total weight loss attributable to lean mass was broadly comparable between treatment approaches.^12,13 These findings do not establish that incretin therapy universally causes clinically significant sarcopenia.

The more clinically useful questions for podiatrists are:

• Has the patient experienced substantial or rapid weight loss?
• Is there evidence of weakness or functional decline?
• Is the patient consuming adequate protein and overall nutrition?
• Is resistance exercise medically appropriate?
• Is muscle preservation particularly important because of age, frailty, complex reconstruction, or prolonged rehabilitation?

Patients with diabetic foot disease, Charcot neuroarthropathy, major reconstruction, or prolonged postoperative immobilization may have substantial functional demands. Therefore, body composition and functional status may deserve attention when clinically relevant.¹⁴

Evidence grade: Level I–II for body-composition effects; insufficient direct evidence regarding specific podiatric functional outcomes.

Weight Loss and Biomechanical Adaptation

Substantial weight reduction may alter mechanical loading and activity patterns. These changes may be beneficial by reducing overall load on the foot and ankle, but patients may also increase physical activity after weight loss and subsequently develop overuse injuries.

When evaluating new lower extremity symptoms, as part of their comprehensive work-up, clinicians should assess activity progression, footwear, gait mechanics, preexisting deformity, and tendon or joint pathology. Podiatrists should avoid attributing every new lower extremity symptom to peptide therapy.

Evidence grade: Level II–III; direct peptide-specific podiatric biomechanical evidence remains limited.

Wound Healing and Nutritional Considerations

Chronic lower extremity wound healing depends on multiple factors, including perfusion, infection control, pressure redistribution, glycemic management, immune function, and adequate nutritional status.

A patient receiving appetite-suppressing therapy may experience a clinically important reduction in caloric or protein intake. This does not mean that GLP-1 therapy is inherently harmful to wound healing. Improved metabolic health may theoretically benefit some patients. However, inadequate nutrition may be detrimental to patients with chronic wounds or high metabolic demands associated with major surgery.

Clinicians should therefore avoid 2 unsupported conclusions: that GLP-1 therapy directly heals diabetic foot ulcers, or that GLP-1 therapy inherently impairs wound healing.

The more evidence-based approach is to evaluate the individual patient's wound status, perfusion, glycemic control, nutritional intake, and weight trajectory. Standard principles of diabetic foot care remain essential, including appropriate vascular assessment, infection management, offloading, wound care, and multidisciplinary treatment.^15,16

Evidence grade: Level I for established wound-care principles; insufficient evidence for GLP-1 therapy as a direct wound-healing treatment.

Investigational Regenerative Peptides

BPC-157. BPC-157 has received considerable attention through online wellness, athletic, and regenerative-medicine communities. Preclinical studies have reported biologic effects involving pathways related to tissue repair, angiogenesis, inflammation, and musculoskeletal healing. However, biologic activity in experimental models should not be equated with demonstrated clinical efficacy.¹⁷

Human evidence exists but remains limited and heterogeneous. The FDA's 2026 review identified several reports of human exposure. A placebo-controlled phase 1 tolerability and pharmacokinetic study reported 32 healthy subjects randomized to treatment, with 24 receiving BPC-157 by rectal enema at doses of 0.25, 0.5, 1, or 2 mg/kg. The FDA briefing document reports no significant adverse events attributed to single or repeated seven-day treatment; headache and flatulence occurred without an obvious difference in frequency or severity compared with placebo. The study, however, was reported as meeting abstracts rather than a fully published clinical trial, and exposure was limited in duration and route.¹⁸

The FDA review also identified a multicenter randomized, double-blind, placebo-controlled study involving 53 patients with mild-to-moderate ulcerative colitis, in which participants received BPC-157 by rectal enema or placebo for 2 weeks. The FDA briefing materials report that BPC-157 was described as well tolerated, with no difference in the frequency or type of adverse events compared with placebo. However, the available evidence was reported through a meeting abstract, and the study evaluated a gastrointestinal indication and rectal administration rather than lower-extremity disease or injectable treatment.¹⁸

A retrospective chart review also described 17 patients with knee pain who received intra-articular BPC-157 alone or in combination with thymosin β4; 16 patients were contacted for follow-up. The FDA summarized the report as finding that the peptide was well tolerated without noted adverse events. However, the study was retrospective, uncontrolled, involved heterogeneous knee-pain diagnoses, and did not establish structural healing or comparative efficacy.¹⁸

More recently, a small pilot study evaluated intravenous BPC-157 in 2 participants and reported no observed adverse effects during the study period. The extremely small sample size and limited follow-up prevent conclusions regarding clinical efficacy or long-term safety.¹⁹

Taken together, the available human evidence suggests that BPC-157 has been administered to humans in several small or early-stage investigations, but the evidence remains insufficient to establish its efficacy or long-term safety for lower-extremity conditions. Importantly, the human studies identified by FDA involve different formulations and routes of administration, including rectal and intra-articular administration, and should not automatically be extrapolated to commercially marketed subcutaneous or intravenous products. Route, formulation, dose, product characterization, and manufacturing quality may materially affect both efficacy and safety.¹⁸

FDA's 2026 evaluation also identified substantial concerns regarding characterization of BPC-157-related bulk drug substances. FDA noted inconsistent naming conventions, limited information regarding impurities and aggregation, inadequate information concerning microbial bioburden and bacterial endotoxins for certain proposed formulations, and potential immunogenicity associated with impurities and peptide aggregates, particularly for injectable or nasal formulations.¹⁸

Evidence grade: Level IV for the limited human clinical evidence; Level V for most regenerative and mechanistic evidence. Insufficient evidence currently exists to recommend BPC-157 as routine treatment for lower-extremity wounds, tendon disorders, postoperative healing, or other podiatric conditions.

Thymosin β4 and TB-500. Thymosin β4 (Tβ4) is an endogenous 43-amino-acid peptide involved in cellular processes including actin regulation, cell migration, angiogenesis, and tissue remodeling.^20,21

TB-500 is generally described as a synthetic, N-acetylated fragment corresponding to residues 17-23 of thymosin β4 (Ac-LKKTETQ), which includes a region involved in actin binding.^22,23 Although the compounds are structurally related, TB-500 is not identical to full-length thymosin β4, and findings from studies of full-length Tβ4 should not automatically be extrapolated to TB-500.

In a rat full-thickness wound model, full-length thymosin β4 was associated with accelerated reepithelialization and other measures of wound repair compared with control treatment.²⁴ However, these findings cannot be directly extrapolated to human lower-extremity wounds or to commercially marketed injectable products.

Podiatrists should also avoid assuming that every product marketed as “TB-500” is pharmacologically interchangeable with endogenous thymosin β4. Differences in molecular structure, formulation, manufacturing, route of administration, and dosing may be clinically important.

The FDA's 2026 evaluation of TB-500 identified discrepancies in the characterization of the nominated substances, including differences between the nominated TB-500 free base and material identified in an accompanying certificate of analysis. FDA also noted inconsistencies in chemical information and concluded that the substances were not adequately characterized. The FDA evaluation identified insufficient clinical and nonclinical safety information and specifically noted the absence of identified human data for drug products containing TB-500, as well as potential immunogenicity associated with injectable administration, peptide aggregation, and peptide-related impurities.²²

In July 2026, the FDA Pharmacy Compounding Advisory Committee reviewed TB-500 free base and TB-500 acetate for potential inclusion on the Section 503A Bulks List and recommended inclusion following an advisory vote. This recommendation was nonbinding and did not constitute FDA approval or, by itself, establish an immediate change in compounding status. The FDA's scientific evaluation had recommended against inclusion because of limitations in characterization and insufficient safety and effectiveness information.^22,25

Evidence grade: Primarily Level V for preclinical regenerative evidence; insufficient evidence to support routine use of TB-500 for lower-extremity wound healing, tendon disorders, or postoperative recovery.

FDA Regulatory Status of BPC-157 and TB-500

Neither BPC-157 nor TB-500 is an FDA-approved treatment for lower-extremity disorders or other medical conditions. In July 2026, the FDA Pharmacy Compounding Advisory Committee reviewed BPC-157-related and TB-500-related bulk drug substances for potential inclusion on the Section 503A Bulks List.25 The committee's recommendations were advisory and nonbinding. An advisory committee recommendation does not constitute FDA approval and does not, by itself, place a substance on the 503A Bulks List or establish immediate authorization for routine pharmacy compounding.²⁵

This distinction is clinically important. FDA staff evaluations recommended against inclusion of both BPC-157-related and TB-500-related bulk drug substances. For BPC-157, FDA identified concerns regarding inadequate physicochemical characterization, limited safety information, potential immunogenicity, peptide-related impurities and aggregation, and insufficient evidence of effectiveness for the indication evaluated.¹⁸ For TB-500, FDA similarly identified inadequate characterization and insufficient clinical and nonclinical information to establish safety or effectiveness. The FDA specifically noted the absence of identified human exposure data for drug products containing TB-500 and potential immunogenicity concerns associated with injectable administration, peptide aggregation, and impurities.²²

Accordingly, the July 2026 PCAC recommendations should not be interpreted as evidence that BPC-157 or TB-500 has been approved by the FDA, demonstrated to be effective, or established as safe for routine clinical use. Podiatrists should distinguish among FDA approval, advisory committee recommendations, inclusion on a compounding bulk-drug list, and evidence of clinical efficacy. These are separate regulatory and scientific determinations.

Growth Hormone Secretagogues. Compounds such as CJC-1295 and ipamorelin are marketed in some settings for body composition, recovery, or anti-aging purposes. CJC-1295 is a long-acting analog of growth hormone-releasing hormone that has been shown in healthy adults to produce sustained increases in growth hormone and IGF-1 concentrations, whereas ipamorelin is a growth hormone-releasing peptide that stimulates growth hormone secretion.^26,27

Potential clinical concerns associated with excessive or sustained activation of the growth hormone/IGF-1 axis include fluid retention, changes in glucose metabolism, and musculoskeletal effects. FDA has also identified safety and product-characterization concerns for compounded CJC-1295 and ipamorelin-related products. FDA reports limited clinical data for CJC-1295 and has identified serious adverse events associated with CJC-1295, including increased heart rate and systemic vasodilatory reactions. FDA also identifies concerns regarding immunogenicity, aggregation, and peptide-related impurities for certain routes of administration.²⁸

These agents should not be grouped with GLP-1 receptor agonists simply because both are commercially described as “peptides.” Growth hormone secretagogues act primarily through growth hormone-releasing hormone or growth hormone secretagogue pathways to increase growth hormone and downstream IGF-1 signaling, whereas GLP-1 receptor agonists activate GLP-1 receptors to influence glucose-dependent insulin secretion, glucagon physiology, appetite, and gastrointestinal motility.^5,26-28

Evidence grade: Variable, generally Level II–V depending on the specific compound and indication; insufficient evidence for routine podiatric use for tissue regeneration.

Compounded and Unapproved Peptide Products

The peptide marketplace includes compounded, online, and commercially marketed products. Safety concerns may arise not only from the pharmacology of the peptide itself but also from dosing errors, concentration variability, inaccurate labeling, sterility concerns, product-quality problems, and inappropriate administration instructions.

The FDA has reported dosing errors involving compounded injectable semaglutide, including confusion between milligrams, milliliters, and syringe units. Such errors have resulted in serious adverse events, including severe gastrointestinal symptoms and dehydration.²⁹

Compounded drugs are not FDA-approved and are not reviewed before marketing for safety, effectiveness, or quality in the same manner as approved medications.³⁰ This distinction is particularly important when patients obtain products through online vendors or other sources and are unable to provide reliable information regarding formulation, concentration, or manufacturing.

For podiatrists, the source of the peptide should be documented when clinically relevant. A patient obtaining an FDA-approved medication from a licensed pharmacy presents a different medication-safety context from a patient receiving an unlabeled injectable product from an unknown source.

Perioperative Considerations

Medication reconciliation prior to podiatric surgery for patients taking GLP-1 receptor agonists should document the exact medication or peptide, dose and formulation, route of administration, duration of therapy, recent dose escalation, gastrointestinal symptoms, and recent weight loss.

GLP-1 receptor agonists may delay gastric emptying and are commonly associated with gastrointestinal adverse effects such as nausea, vomiting, and constipation. In the perioperative setting, delayed gastric emptying may increase the likelihood of residual gastric contents and potentially increase the risk of regurgitation and pulmonary aspiration during anesthesia or deep sedation. Significant vomiting or reduced oral intake may additionally contribute to dehydration and nutritional compromise.³¹

Risk may be particularly relevant during dose-escalation periods or in patients with substantial gastrointestinal symptoms or other conditions associated with delayed gastric emptying. Current multi-society guidance therefore recommends an individualized approach rather than automatically discontinuing GLP-1 receptor agonists in every patient before surgery.³¹

The final perioperative plan should be individualized and coordinated among the prescribing clinician, anesthesia team, proceduralist, and institutional policy when clinically appropriate. Podiatrists should not independently instruct patients to discontinue prescribed GLP-1 receptor agonists without appropriate clinical coordination.

Conclusion

Peptide therapy is not a single therapeutic category. The clinical implications of semaglutide, tirzepatide, teriparatide, BPC-157, and TB-500 cannot be assumed to be interchangeable.

Some peptide-based therapies have substantial evidence supporting specific clinical indications. Others remain unsupported for many of the uses for which they are commercially promoted. Recent regulatory developments involving BPC-157 and TB-500 further demonstrate why clinicians must distinguish regulatory consideration from regulatory approval. In July 2026, the FDA Pharmacy Compounding Advisory Committee recommended inclusion of both substances on the Section 503A Bulks List; however, these recommendations were nonbinding and did not constitute FDA approval or an immediate authorization for routine compounding. FDA staff evaluations continued to identify substantial concerns regarding characterization, safety, and evidence of effectiveness.^18,22,25

For podiatrists, the most clinically useful approach is neither indiscriminate enthusiasm nor blanket dismissal. Clinicians should identify the specific product and formulation, determine its evidence and regulatory status, recognize potential systemic and lower-extremity complications, and continue evidence-based management of vascular, neurologic, infectious, mechanical, wound, nutritional, and surgical conditions.

For patients with diabetes, peptide therapy may improve important metabolic risk factors but does not replace routine foot surveillance. For patients undergoing substantial weight loss, attention to nutrition, muscle function, and rehabilitation may be appropriate. For patients using investigational or nonapproved regenerative peptides, clinicians should communicate the limitations of the evidence clearly and avoid allowing unproven therapies to delay established diagnosis and treatment.

Ultimately, podiatrists do not need to become peptide prescribers to provide excellent care to patients using peptide therapies. They need to recognize what the patient is taking, understand the quality and limitations of the evidence, distinguish FDA approval from regulatory consideration, identify potential complications, and integrate that information into comprehensive lower-extremity care.

Dr. Santangelo is the Director of the Podiatric Residency Program at Norwegian American Hospital in Chicago.

Student Doctor Momenibigdeli is a fourth-year student at The Dr. William M. Scholl College of Podiaric Medicine at Rosalind Franklin University.

The authors have no non-financial or commercial, proprietary, or financial interest in the products or companies described in the manuscript. The author(s) did not receive grants or a consultant honorarium to conduct the study, write the manuscript or otherwise assist in the development of the above-mentioned manuscript.

The authors disclose that artificial intelligence tools were used for literature organization and language editing. The authors independently reviewed and revised the manuscript, verified the scientific content and cited sources, and retains full responsibility for the accuracy, originality, and final content of the submission.

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