Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

Diabetic Foot Ulcer Clinical Trial

Official title:

A Randomized Controlled Multicenter Trial Examining the Effect of Derm-Maxx ADM on the Healing Rate of Chronic Diabetic Foot Ulcers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455475
• Other study ID #: RADMAX
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: Capsicure, LLC
• Contact: Sarah Moore, BSN, MBE
• Phone: 512-571-2966
• Email: smoore[@]capsicure.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers

Description:

This is a multicenter randomized open-label clinical study in patients with Wagner grade 1 and 2 DFUs. Diabetic patients presenting with chronic nonhealing ulcers will be screened for eligibility. At least 50% of the eligible population will be drawn from patients ≥ 65 years of age. All patients will complete a 2-week run-in period prior to treatment allocation to Derm-Maxx and standard of care (SOC) or SOC alone. Patients will be seen at weekly intervals (± 3 days) for the 12 weeks treatment period. If additional dressing changes are required between the scheduled visits, the occurrence of these visits will be recorded. Primary efficacy endpoints include percentage change in ulcer size at 12 weeks along with the proportion of participants achieving complete wound closure. Additionally, pain and safety will be assessed as secondary endpoints.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects are male or female, 18 years of age or older. At least 50% of the enrolled population must be = 65 years of age.
• Subjects with one of the following wounds: Diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
• Objectively, less than 20% healing in the two-week run-in period prior to randomization
• Study ulcer is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
• Subjects' wound score on ISDA tool is Grade 1 or 2.
• The subject is able and willing to follow the protocol requirements
• Subject has signed informed consent
• Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of = 30 mmHg; an ABI between 0.7 and = 1.3, or TBI of >6 within 3 months of the first Screening Visit.
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation
• The target ulcer has been offloaded for at least 14 days prior to randomization.

Exclusion Criteria:

• Subject has a known life expectancy of < 1 year
• Subject is unable to comply with offloading device
• Subject has ulcers that are completely necrotic or fibrotic tissue
• Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
• Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
• The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety
• Known contraindications to acellular dermal matrices
• Known allergies to any of the Derm-Maxx components
• Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
• Index ulcer has reduced in area by 20% or more after 2 weeks of standard of care from the first screening visit (S1) to the TV1/randomization visit.
• Subject is pregnant or breast feeding.
• Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days prior to randomization visit or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
• Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first treatment visit.
• Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1.
• Known HbA1C >12%
• An ulcer that has visible signs of improvement in the four weeks prior to randomization defined objectively as a 40% reduction in surface area in the four weeks prior to enrollment.
• An ulcer that has healed by more than 20% in the 2 weeks prior to screening:

"historical" run-in period.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Other:
• Derm-Maxx
Derm-Maxx™ Dermal Matrix is an acellular human dermis graft sterilized using the Tutoplast® Tissue Sterilization Process.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capsicure, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Closure Assessment Verified with Independent Adjudication	To demonstrate increased healing rates of chronic wounds (diabetic foot ulcers), unresponsive to standard therapy.	12 weeks
Secondary	Ease of Implementation Assessed with Provider and Patient Questionnaire	To demonstrate the ease of implementing Derm-Maxx as an addition to standard therapy regimens.	12 weeks