Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT07260656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain
Sponsor:
Carilion Clinic
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Pilot Study to Investigate the Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: