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Derm-Maxx for Diabetic Foot

Verified Trial
N/A
Waitlist Available
Led By Windy Cole, DPM
Research Sponsored by Capsicure, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is your foot ulcer between 2-25cm2? (ie is it bigger than a quarter but smaller than a tennis ball?)
Has your foot ulcer been present for at least a month but no longer than a year?
Must not have
Does your foot ulcer expose tendon or bone?
Is your foot ulcer infected or has it been infected recently?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial tests whether using Derm-Maxx alongside standard treatment helps diabetic patients with foot ulcers."

Who is the study for?
This trial is for adults with Type I or II Diabetes who have a diabetic foot ulcer that hasn't improved with standard treatments. The ulcer should be on the foot, present for 4 weeks to less than a year, and not healing well. Participants must have good blood flow to their feet and be willing to follow study rules.
What is being tested?
The study tests Derm-Maxx as an additional treatment for diabetic foot ulcers alongside usual care. It's a randomized controlled trial, meaning patients are randomly assigned to receive either Derm-Maxx or no extra treatment in addition to their current care.
What are the potential side effects?
Potential side effects of Derm-Maxx aren't specified here but could include skin irritation at the application site, allergic reactions, or infection risks due to the nature of treating open wounds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Wound Closure Assessment Verified with Independent Adjudication
Secondary study objectives
Ease of Implementation Assessed with Provider and Patient Questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Derm-Maxx as an addition to standard of careExperimental Treatment1 Intervention
Device exposure is estimated to be a maximum of 12 weeks
Group II: Standard of careActive Control1 Intervention
Debridement, offloading, and proper moisture balance dressings

Find a Location

Who is running the clinical trial?

Capsicure, LLCLead Sponsor
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Foot Ulcer
150 Patients Enrolled for Foot Ulcer
Windy Cole, DPMPrincipal InvestigatorCapsicure, LLC
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Foot Ulcer
150 Patients Enrolled for Foot Ulcer
Sarah Moore, BSN, MBEStudy DirectorCapsicure, LLC
~100 spots leftby Sep 2025
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