Trial Summary
What is the purpose of this trial?
This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers
Research Team
WC
Windy Cole, DPM
Principal Investigator
Capsicure, LLC
SM
Sarah Moore, BSN, MBE
Principal Investigator
Capsicure, LLC
Eligibility Criteria
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.Inclusion Criteria
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?
Exclusion Criteria
Is your foot ulcer infected or has it been infected recently?
Does your foot ulcer expose tendon or bone?
Treatment Details
Interventions
- Derm-Maxx (Other)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You
Who Is Running the Clinical Trial?
Capsicure, LLC
Lead Sponsor
Trials
2
Recruited
300+