Actively Recruiting
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
Led by HealthTech Wound Care · Updated on 2025-12-23
150
Participants Needed
10
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical evaluation is to collect patient outcome data and evaluate the efficacy, safety and tolerability of HealthTech DermaBind TL™ in patients with chronic non-healing wounds in patients with chronic non-healing ulcers.
CONDITIONS
Official 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) on the plantar, lateral, or dorsal aspect of the foot below the medial malleolus
- Have a diagnosis of Type I or Type II diabetes mellitus with stable anti-diabetic treatment or diet control
- A1C must be equal to or less than 10% within the last 30 days or confirmed during screening
- Have a single target ulcer with an area between greater than 1 cm2 and less than 25 cm2 that does not probe to bone
- Ulcer present for more than 4 weeks and less than 1 year prior to consent
- Absence of infection based on clinical and radiographic evidence before treatment
- Adequate circulation to the affected lower limb confirmed by specific vascular tests
- Ability to comply with off-loading and dressing change requirements
- Non-tobacco user for at least 4 weeks prior to initial graft application
- Ability to understand study requirements and provide informed consent
- Life expectancy greater than 6 months
- Failed conservative wound care treatment for at least 4 weeks
- No need for negative pressure therapy, antimicrobial dressings, or hyperbaric oxygen therapy during the study
- No radiation therapy to the ulcer site
- Ulcer base clean and free of necrotic tissue and infection at treatment start
- Off-loading of the ulcer with a CAM boot or total contact cast for at least 14 days before treatment
- Females of childbearing potential must agree to contraception and pregnancy testing during the study
You will not qualify if you...
- Pregnant or breastfeeding
- Under 18 years of age
- Current tobacco or nicotine use
- Wound size decreased by 30% or more between screening and treatment visits
- Wound showing signs of healing likely to continue without treatment
- Hemoglobin A1c above 10% within 30 days before screening
- Serum creatinine level 3.0 mg/dL or higher within 30 days before screening
- Use of biomedical or topical growth factors within 30 days before screening
- Need for dressings not approved by the study
- Osteomyelitis or bone infection of the affected foot within 30 days before screening
- Inability to tolerate off-loading devices
- Known or suspected immune system disease
- Active or untreated cancer or uncontrolled connective tissue disease
- Recent or ongoing use of immune-suppressing medications or topical steroids to the ulcer within 1 month before screening
- Presence of necrosis, pus, or sinus tracts at the ulcer site that cannot be removed by debridement
- Revascularization procedure within 4 weeks before baseline visit
- Liver enzyme levels more than three times the normal upper limit within 30 days before screening
- Uncontrolled swelling, lymphedema, or venous hypertension in the affected limb
- Treatment with living skin equivalent or placental-derived allograft within 4 weeks before screening
- Conditions placing the participant at undue risk or affecting data quality
- 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
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
CONTACT
J
Jessica Study Coordinator, NP-C, WCC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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