A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHealthTech Wound Care
About this trial
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.
Eligibility criteria
Qualifiers
1. Be an adult between 18 and 80 years of age at the time of consent 2. Presence of a DFU, Wagner Grade 1 or 2 (see Appendix A for definitions) on the plantar, lateral or dorsal aspect of the foot, extending through the dermis provided it is below the medial aspect of the malleolus.
for Type I DM, have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit, or
for Type II DM, must have been on a stable anti-diabetic medication for at least 30 days, or if diet-controlled only, must have been on stable diet-control for at least 6 months.
TCOM ≥30 mmHg
Disqualifiers
1. Pregnant or lactating 2. Less than 18 years of age 3. Has continued tobacco use 4. Have a wound that decreased in size ≥30% between the Screening and Treatment Visits 5. Wound is showing signs of healing and that improvement is likely to continue without treatment (increased granulation, epithelization, decrease in size ≥ 30% reduction in wound surface area).
Trial design
Treatments tested in this trial
- DermaBind TL
Treatment groups
150 Participants
are divided into 1 treatment groupLocations
10Florida
Midland Florida Clinical Research Center32720, DeLand United States
Pharmakon Medical Research33410, Palm Beach Gardens United States
Vital Medical Research33174, Sweetwater United States
Michigan
EMbassy Research Network48302, Bloomfield Township United States
Sponsors and collaborators
HealthTech Wound Care
Lead sponsor
Source ClinicalTrials.gov