Actively Recruiting
Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
Led by Capsicure, LLC · Updated on 2025-04-30
150
Participants Needed
11
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers
CONDITIONS
Official Title
Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older; at least 50% of participants must be 65 years or older
- History of Type I or Type II Diabetes Mellitus treated with oral medication or insulin
- Presence of a Wagner grade 1 or 2 diabetic foot ulcer at or below the medial malleolus
- Ulcer present for more than 4 weeks but less than 12 months while receiving standard care
- Less than 20% healing observed during a 2-week screening period before randomization
- Ulcer size between 1.0 cm2 and 25 cm2 after debridement at first treatment visit
- Prior infection of ulcer or limb is allowed if adequately treated and controlled
- Ability and willingness to follow the study protocol
- Signed informed consent
- Adequate blood flow to the affected foot confirmed by specific oxygen or pressure measurements within 3 months
- Negative pregnancy test for women of childbearing potential; use of birth control during participation
- Ulcer offloaded with a study-defined device for at least 14 days before randomization
- Ulcer base clean and free of dead tissue at treatment application
You will not qualify if you...
- Life expectancy less than 1 year
- Ulcer present for more than 1 year
- Insufficient healing data showing less than 20% area reduction during screening
- Inability to use offloading device
- Conditions that seriously impair ability to complete the study or history of poor treatment adherence
- Ulcers that are completely dead or fibrotic tissue
- Major uncontrolled medical disorders including serious heart, kidney, liver, lung disease, lupus, palliative care, or sickle cell anemia
- Active cancer treatment or history of cancer in the ulcer area
- Other conditions that may compromise safety as judged by the investigator
- Known allergy or contraindication to acellular dermal matrices or Derm-Maxx components
- Participation in another clinical trial with interfering investigational drug or device
- Ulcer area reduced by 20% or more after 2 weeks of standard care before randomization
- Pregnancy or breastfeeding
- Recent or anticipated treatment with immunosuppressants or chemotherapy within 30 days before randomization
- Recent treatment of ulcer with tissue-engineered or scaffold materials within 30 days
- Need for hyperbaric oxygen therapy during the trial or within 2 weeks before screening
- Poor diabetes control with HbA1c of 12.0 or higher within 30 days before randomization
- Ulcer or limb with gangrene or unstable blood flow at screening
- Recent revascularization surgery on the affected lower extremity within 30 days
- Ulcer suspected to be cancerous requiring biopsy
- Any other significant health risks or findings that may affect study participation or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
North Alabama Research Center, LLC
Athens, Alabama, United States, 35611
Actively Recruiting
2
Premium Podiatry
Encino, California, United States, 91316
Actively Recruiting
3
Royal Research
Hollywood, Florida, United States, 33024
Actively Recruiting
4
Bioresearch Partner
Miami, Florida, United States, 33175
Actively Recruiting
5
Bioresearch Partner
Miami Lake, Florida, United States, 33016
Actively Recruiting
6
Wahab Research
Las Vegas, Nevada, United States, 89148
Actively Recruiting
7
Premium Foot and Ankle
Sanford, North Carolina, United States, 27330
Actively Recruiting
8
Ohio Foot and Ankle Specialists
Ashtabula, Ohio, United States, 44004
Actively Recruiting
9
Cleveland Foot and Ankle Clinic
Cleveland, Ohio, United States, 44103
Actively Recruiting
10
ABC Podiatry
Columbus, Ohio, United States, 43213
Actively Recruiting
11
Olympus Clinical Research
Sugar Land, Texas, United States, 77478
Actively Recruiting
Research Team
M
Marissa Docter, RN, BSN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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