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New treatment option for Diabetic Foot Ulcer (DFU)
Official title A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
ClinicalTrials.gov ID: NCT07172893
What this study is testing
What is DermaBind TL?
DermaBind TL is an investigational medicine, being studied as a potential treatment for diabetic foot ulcer (dfu).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
- TCOM ≥30 mmHg
- ABI between 0.7 and 1.3
You likely can't join if
- 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...
- 6\. Circulating hemoglobin A1c exceeding 10% within 30 days of the Screening Visit 7. Serum creatinine concentrations of 3.0 mg/dL or greater within...
- 11\. The inability to tolerate off-loading (a surgical shoe, removable cast walker or a total contact cast) 12. Have a known or suspected disease of...
- 15\. At the index ulcer site, presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement 16. Had undergone a...
- 23\. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- 24\. people with a previous diagnosis of HIV or Hepatitis C, regardless of current status .
See the full eligibility criteria
- 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...
- 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. 4\. For Type I and Type II DM, A1C must...
- 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. 12\. Have the...
- 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...
- 6\. Circulating hemoglobin A1c exceeding 10% within 30 days of the Screening Visit 7. Serum creatinine concentrations of 3.0 mg/dL or greater within 30 days prior to screening 8. The wound has been treated with...
- 11\. The inability to tolerate off-loading (a surgical shoe, removable cast walker or a total contact cast) 12. Have a known or suspected disease of the immune system 13. Have an active or untreated malignancy or...
- 15\. At the index ulcer site, presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement 16. Had undergone a revascularization procedure aimed at increasing blood flow in the treatment target...
- 23\. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- 24\. people with a previous diagnosis of HIV or Hepatitis C, regardless of current status .
The study team makes the final eligibility decision.
Where it's taking place
- DeLand, Florida, United States
- Palm Beach Gardens, Florida, United States
- Sweetwater, Florida, United States
- Bloomfield Township, Michigan, United States
- Cary, North Carolina, United States
- Raleigh, North Carolina, United States
- Blue Ash, Ohio, United States
- Boardman, Ohio, United States
- Houston, Texas, United States
- Salem, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include DeLand, Florida, United States; Palm Beach Gardens, Florida, United States; Sweetwater, Florida, United States; Bloomfield Township, Michigan, United States; Cary, North Carolina, United States; Raleigh, North Carolina, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.