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 groupSponsors and collaborators
Source ClinicalTrials.gov