An Early Phase 1 interventional study of Capsaicin Palmitate and Placebo in Diabetic Neuropathies, Painful, Diabetic Foot and Diabetic Peripheral Neuropathy, sponsored by Carilion Clinic. Recruiting at 1 site in United States. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Carilion Clinic · Early Phase 1, Interventional, and Treatment
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Among 381 studies in Diabetic Foot with a site in United States — 66 open to participants now, 85 under way, 3 of them phase 3. Diabetic Foot · United States.
Among the 381 studies in Diabetic Foot with a site in United States, this one is the 135th largest by planned enrollment of the 322 interventional ones that give a count, is one of 30 that started in 2025, is one of 19 in phase 1, reaches primary completion later than 73 of the 84 other live ones, and was the 366th registered.
1,078 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
Browse Diabetic Foot studies →66 of the 381 studies in Diabetic Foot with a site in United States are open now. Recruiting first, the newest first:
Applied Biologics, LLC · Sites in United States
Ages 18+
Biodynamik, Inc · Sites in United States
Ages 22+
Lakewood-Amedex Inc · Sites in United States
Ages 18+
Capsicure, LLC · Sites in United States
Ages 18+
Reprise Biomedical, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 25 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
381 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 54 · Phase 3 37 · Phase 4 31
First in 1994; this study’s year is marked. 30 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is above the median of 60 across 848 interventional studies indexed under Diabetic Foot.
Median enrollment 60 across the 322 interventional studies, 138 across the 58 observational. Of the 249 that completed or were terminated, 89 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
253 of 381 have an industry lead sponsor. The 10 most frequent:
Carilion Clinic is the lead sponsor of 75 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 2 (22%) have results posted.
Carilion Clinic has 1 study filed under Diabetic Foot — fewer than ten, so there is no comparison to draw.
34 of the studies in Diabetic Foot with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05369052Phase 3MicuRxSafety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI) | 2027-06-30 |
| NCT07852338Phase 3Applied Biologics, LLCa Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers | 2027-09 |
| NCT06420245Legacy Medical ConsultantsClinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management | 2026-11 |
| NCT06449638StimLabsModified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs | 2026-11 |
| NCT06681428Tides MedicalRising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | 2026-11-18 |
Add all 34 to your calendar (.ics) → With an account.
Among the 381 studies in Diabetic Foot with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this research is to assess whether the use of a topical cream with an active ingredient can reduce the amount of foot pain experienced in participants who have been diagnosed with Diabetic Peripheral Neuropathy (DPN) with minimal side effects or discomfort from use.
This is a double-blind, randomized, placebo-controlled trial with two arms to assess the pain-reducing effects of topical Capsadyn compared to a placebo (carrier cream). At the appointment/recruitment visit, patients will receive standard of care as determined by their clinician. At the first visit, participants opting into the trial will not receive any new medications designed for producing pain relief alongside the Test Article but will continue medications taken before entry to the study, if use history is stable, or medications not specifically designed for pain reduction. Both the clinician administering the Test Article and the participant will be blinded to Test Article, or unaware of whether it is Capsadyn or placebo.
A Test article can be administered to either a unilateral area, or bilateral painful areas. Test Article should be administered over the complete painful area. Test Articles will be packaged in coded, white-labeled one-ounce plastic jars, marked only with a code indicating Capsadyn or placebo, and sent to Carilion Pharmacy for distribution to healthcare providers. The pharmacy will quarantine the Test Articles and randomize Test Article scheduling between the two arms. The participant population will be scheduled for an even split between the two study arms. With the recruitment of 40 participants (20 per group), an interim look at the data will be done to assess participant compliance with instructions, general progress of the study and to troubleshoot any issues that may have arisen.
1,078 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 848 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Carilion Clinic is the lead sponsor of 75 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 2 (22%) have results posted.
Compared within Diabetic Foot, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetic Neuropathies. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
participant will receive an over-the-counter topical cream with .25% capsaicin palmitate
Drug: Capsaicin Palmitate
participant will receive an over-the counter topical cream with no active ingredient
Drug: Placebo
Participant will apply a small amount of topical cream (size of a quarter) to one or both feet twice a day, once in the morning and once in the evening.
Also known as: Capsadyn
Participant will apply a small amount of topical cream (size of a quarter) to one or both feet twice a day, once in the morning and once in the evening.
Also known as: OTC topical cream
Significant reduction in foot pain in participants with chronic diabetic neuropathic foot pain.
Participants will complete a Numeric Rating Scale (NRS) twice a day for 14 days one hour after applying topical cream to the area of their foot where they are experiencing Diabetic Peripheral Neuropathy foot pain. Participants will not be aware of whether the topical cream applied includes capsaicin palmitate. The NRS rates the intensity of symptoms with a scale of 0 to 10 with 0 being no symptom present to 10 being the worst possible intensity. The symptoms being assessed include redness, irritation, itching, tingling, and a burning or cooling sensation one hour after applying the topical cream. Study investigators will review the variances in the NRS ratings throughout the duration of the 14 days of all participants and report any changes from baseline scores. Data will be analyzed using one-way repeated measures ANOVA, followed by the Mann-Whitney U post-hoc test. Data will be visualized as box-and-whisker plots, comparing Capsadyn to placebo.
Time frame: A NRS will be completed by the participant twice a day, once in the morning and once in the evening, for 14 days after each application of the topical cream provided
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2027, 24 months after the start.
Of 26 phase 1 interventional studies under Diabetic Foot, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 43. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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Carilion Clinic