Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
- Conditions
- Diabetic Foot Ulcer
- Registration Number
- NCT06455475
- Lead Sponsor
- Capsicure, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria:<br><br> 1. Subjects18 years of age or older. At least 50% of the enrolled population must be ><br> 65 years of age.<br><br> 2. Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral<br> medications and/or insulin replacement therapy.<br><br> 3. Subjects with the following ulcer:<br><br> A. Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening<br> visit on any aspect of the foot, provided it is at or below the aspect of the medial<br> malleolus. [NOTE: If two or more DFUs are present with the same grade, the index<br> ulcer is the largest ulcer and the only one evaluated in the study. Index ulcer must<br> be more than 5 cm distant apart].<br><br> B. A diabetic foot ulcer present for greater than 4 weeks (documented in the medical<br> record) but less than 12 months duration if being treated with active SOC.<br><br> 4. Objectively, less than 20% healing in the two-week screening period prior to<br> randomization.<br><br> 5. Study ulcer is a minimum of 2.0 cm2 and a maximum of 25 cm2 post-debridement at<br> first treatment visit.<br><br> 6. Index ulcer and/or index ulcer limb may have had prior infection, but infection(s)<br> must be adequately treated and controlled as defined by IDSA Guidelines Grade level<br> 1.<br><br> 7. The subject is able and willing to follow the protocol requirements.<br><br> 8. Subject has signed informed consent.<br><br> 9. Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous<br> oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of = 30<br> mmHg; an ABI between 0.7 and = 1.3, or TBI of >6 within 3 months of the first<br> Screening Visit.<br><br> 10. Negative pregnancy test for females of childbearing potential (e.g., not post-<br> menopausal for at least one year or surgically sterile). Females of childbearing<br> potential must be willing to use acceptable methods of contraception (birth control<br> pills, barriers, or abstinence) starting at Screening and continuing through the<br> duration of their study participation.<br><br> 11. The index ulcer has been offloaded with protocol defined offloading device<br> throughout the study run-in period for at least 14 days prior to randomization (Run-<br> in period defined as Screening through TV1/Randomization).<br><br> 12. The index ulcer has a clean base and is free of necrotic debris at time of placement<br> of treatment product.<br><br>Exclusion Criteria:<br><br> 1. Subject has a known life expectancy of < 1 year.<br><br> 2. Index ulcer has been present for >1 year.<br><br> 3. Patient does not have adequate 2-week historical data demonstrating < 20% area<br> reduction.<br><br> 4. Subject is unable to comply with offloading device.<br><br> 5. Presence of any condition(s) which seriously compromises the subject's ability to<br> complete this study or has a known history of poor adherence to medical treatment.<br><br> 6. Subject has ulcers that are completely necrotic or fibrotic tissue<br><br> 7. Subject has major uncontrolled medical disorders such as serious cardiovascular,<br> renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.<br><br> 8. Subject currently being treated for an active malignant disease or subjects with<br> history of malignancy within the ulcer.<br><br> 9. The Subject has other concurrent conditions that in the opinion of the Principal<br> Investigator may compromise subject safety.<br><br> 10. Known contraindications to acellular dermal matrices or known allergies to any of<br> the Derm-Maxx components.<br><br> 11. Concurrent participation in another clinical trial that involves an investigational<br> drug or device that would interfere with this study.<br><br> 12. Index ulcer has reduced in area by 20% or more after 2 weeks of standard of care<br> from the first screening visit (S1) to the TV1/randomization visit.<br><br> 13. Subject is pregnant or breastfeeding.<br><br> 14. Subjects with a history of more than two weeks treatment with immunosuppressants<br> (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or<br> application of topical steroids to the ulcer surface within 30 days prior to<br> randomization visit or who receive such medications during the screening period, or<br> who are anticipated to require such medications during the course of the study.<br><br> 15. Index ulcer has been previously treated with tissue engineered materials (e.g.<br> Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within<br> the last 30 days preceding the first treatment visit.<br><br> 16. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of<br> screening visit 1.<br><br> 17. Presence of diabetes with poor metabolic control as documented with an HbA1c =12.0<br> within 30 days of randomization (TV1).<br><br> 18. Index ulcer and/or index limb with presence of gangrene or unstable ischemia at<br> screening (SV1).<br><br> 19. Revascularization surgery on the lower extremity on which the index ulcer is located<br> within 30 days of Screening Visit (SV1).<br><br> 20. Index ulcer in the opinion of the Principal Investigator, is suspicious for cancer<br> and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.<br><br> 21. Any clinically significant finding, in the judgment of the Principal Investigator,<br> that would place the subject at health risk, impact the study, or affect the<br> completion of the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound Closure Assessment Verified with Independent Adjudication
- Secondary Outcome Measures
Name Time Method Ease of Implementation Assessed with Provider and Patient Questionnaire