RecruitingPhase 4

A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL

United States150 participantsStarted 2025-12-10

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. ABI between 0.7 and 1.3
✓. SPP \>30 mmHg
✓. As an alternative, Arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle on the extremity the index ulcer is located.

What they're measuring

Measure the protective effect of the wound covering on the wound over the 13-week treatment period

Timeframe: 13 weeks

Trial details

NCT IDNCT07172893

SponsorHealthTech Wound Care

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-21

Contact for this trial

Doug Schmid Chief Scientific Officer, PhD

801-556-9799 dschmid@healthtechwc.com

View on ClinicalTrials.gov More Diabetic Foot Ulcer (DFU) trials