Actively Recruiting
A Non-Randomized Open Label Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of DermaBind TL, a Placental Membrane Allograft Intended for Use in the Management of Non-Healing Ulcers
Led by HealthTech Wound Care · Updated on 2025-12-23
150
Participants Needed
10
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness, safety, and tolerability of DermaBind TL, a full-thickness dehydrated placental allograft, in patients with chronic non-healing ulcers, including diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The trial focuses on patients whose wounds have not responded to standard treatments. The study is a prospective, multi-center, open-label, single-arm clinical trial led by HealthTech Wound Care, designed to collect outcome data over a 12-week treatment period. Participants will receive DermaBind TL applied to their wounds while following standard care, including offloading with devices like CAM boots or total contact casting, wound debridement, infection management, and layered dressings for protection. The treatment phase lasts 12 weeks with assessments for wound area protection, infection rates, and adverse events. The study includes a screening phase to determine eligibility before treatment begins. During the study, clinicians will assess wounds regularly to monitor wound size, infection, and healing progress. Data will be collected on the number of grafts used and any treatment-related adverse effects. Outcome measures include wound area preservation and protective effects of the dressing over 13 weeks. Participants must comply with offloading and dressing protocols and will be followed for safety and treatment tolerability throughout the study duration.
CONDITIONS
Brief Title
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be an adult between 18 and 80 years of age at the time of consent
- Have a diabetic foot ulcer, Wagner Grade 1 or 2, located on the plantar, lateral, or dorsal foot below the medial malleolus
- Have a diagnosis of Type I or Type II diabetes mellitus with stable anti-diabetic treatment or diet control for required durations
- Have A1C equal to or less than 10% within the last 30 days or confirmed during screening
- Have a single target ulcer larger than 1 cm2 and less than 25 cm2, present for more than 4 weeks and less than 1 year
- No infection present at the ulcer site as confirmed by Infectious Disease Society criteria and radiographic evidence
- Adequate circulation to the affected lower extremity confirmed by specified vascular tests
- Ability to comply with off-loading and dressing change requirements
- Non-tobacco user for at least 4 weeks before treatment
- Ability to understand study requirements and give informed consent
- Life expectancy greater than 6 months
- Failed conservative wound care for at least 4 weeks
- Willingness of females of childbearing potential to use contraception and undergo pregnancy tests during study
You will not qualify if you...
- Pregnant or lactating individuals
- Under 18 years of age
- Current tobacco or nicotine product use
- Wounds showing significant spontaneous healing or size reduction before treatment
- A1C exceeding 10% within 30 days prior to screening
- Serum creatinine levels of 3.0 mg/dL or greater within 30 days prior to screening
- Wounds treated with biomedical or topical growth factors within 30 days before screening
- Need for additional dressing materials not approved for the study
- Osteomyelitis or bone infection of the affected foot within 30 days prior to screening
- Inability to tolerate off-loading devices
- Known or suspected immune system diseases
- Active or untreated malignancy or uncontrolled connective tissue disease
- Recent or ongoing immunosuppressive treatments
- Presence of necrosis, purulence, or sinus tracts at the ulcer site that cannot be removed by debridement
- Recent revascularization procedure within 4 weeks before baseline
- Elevated liver enzymes above three times normal limits within 30 days prior to screening
- Uncontrolled edema, lymphedema, or venous hypertension in the affected limb
- Recent treatment with living skin equivalents or placental-derived allografts within 4 weeks before screening
- Conditions posing undue risk or jeopardizing data quality as assessed by investigator
- Use of investigational drugs or devices within 30 days before screening
- Ulcers caused by conditions other than diabetes
- History of HIV or Hepatitis C infection regardless of current status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 13 weeks
Participants receive DermaBind TL™ applied to their chronic non-healing ulcers along with standard care including offloading, debridement, infection management, and wound dressings.
Weekly visits for up to 13 weeks
Trial Site Locations
Total: 10 locations
1
Midland Florida Clinical Research Center
DeLand, Florida, United States, 32720
Actively Recruiting
2
Pharmakon Medical Research
Palm Beach Gardens, Florida, United States, 33410
Actively Recruiting
3
Vital Medical Research
Sweetwater, Florida, United States, 33174
Actively Recruiting
4
EMbassy Research Network
Bloomfield Township, Michigan, United States, 48302
Actively Recruiting
5
US Foot and Ankle Specialists-Cary Satellite Site
Cary, North Carolina, United States, 27518
Actively Recruiting
6
US Foot and Ankle Specialists
Raleigh, North Carolina, United States, 27609
Actively Recruiting
7
US Foot and Ankle Specialists
Blue Ash, Ohio, United States, 45242
Actively Recruiting
8
Lower Extremity Institute for Research and Therapy
Boardman, Ohio, United States, 44512
Actively Recruiting
9
Perfizien Clinical Research, LLC.
Houston, Texas, United States, 77055
Actively Recruiting
10
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, United States, 24153
Actively Recruiting
Research Team
D
Doug Schmid Chief Scientific Officer, PhD
J
Jessica Study Coordinator, NP-C, WCC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here