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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
DermaBind TL
Biological/VaccineFull-Thickness Dehydrated Placental Allograft
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Efficacy, Safety, and Tolerability of DermaBind TLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Measure the protective effect of the wound covering on the wound over the 13-week treatment period
Size of wound will be measured using Clock method * 12 o'clock to 6 o'clock: Measure the length of the wound from the top (12 o'clock) to the bottom (6 o'clock). * 9 o'clock to 3 o'clock. Measure the width of the wound from the left (9 o'clock) to the right (3 o'clock). * Depth Measurement: Use a cotton tip applicator to measure the depth. Insert the applicator gently into the deepest part of the wound, mark the point where it meets the wound edge, and measure the length from the tip to the mark. * The area is then calculated as: Area (cm2) = Length (cm) × Width (cm), where length is the longest axis of the index ulcer and width is the longest orthogonal at an axis 90 degrees relative to the length.
Time frame
13 weeksSecondary outcomes
1
Preservation of the wound area over the study period
Determination that the wound area does not increase through the 13 week study. This will be determined by the study physician and verified by an independent third party.
Time frame
13 Weeks2
Monitor the rate of wound infection over the 13 week study
Number of wound infections observed during 13 week study on the study wound. This will be determined by the study physician and verified by an independent third party.
Time frame
13 Weeks3
Average number of DermaBind TL™ grafts used per subject
Count the number of DermaBind TL grafts used per study subject to determine efficiency of use.
Time frame
13 Weeks4
Incidence of treatment-emergent adverse events (TEAEs), including any clinically significant changes in vital signs, ankle-brachial index (ABI), and findings from physical exams, throughout the study period
Time frame
13 WeeksOther outcomes
1
Product Wastage
Total surface area of grafts used minus calculated surface area of index ulcer
Time frame
13 WeeksSponsors and contacts
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Source ClinicalTrials.gov