A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix

NCT06444906 | Not Yet Recruiting FDA Device

• 1 other identifier: DM-DFU-201
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or SOC.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• To determine the efficacy of Dermacyte Matrix compared to SOC based on total wound closure

  Wound healing will be assessed by observation of skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits at least 2 weeks apart.

  12 weeks

Secondary Outcomes (2)

• To determine the safety of Dermacyte Matrix compared to SOC

  12 weeks

• To determine the heal rate of DFU for Dermacyte Matrix and SOC

  12 weeks

Other Outcomes (1)

• To measure change in quality of life (QoL)

  12 weeks

Study Arms (2)

Dermacyte Matrix

ACTIVE COMPARATOR

Dermacyte Matrix will be applied topically in conjunction with SOC on a weekly frequency and dosed by square centimeters to match the ulcer surface area.

Device: Dermacyte Matrix

Standard of Care

OTHER

SOC therapy will consist of weekly debridement of nonviable tissue as clinically indicated, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated.

Other: Standard of Care (SOC)

Interventions

Dermacyte Matrix DEVICE

The appropriate square centimeters of Dermacyte Matrix is applied directly to the target DFU that is free of debris and necrotic tissue. The Dermacyte Matrix will be applied at weekly intervals or for up to 10 applications.

Dermacyte Matrix

Standard of Care (SOC) OTHER

SOC therapy will consist of debridement of nonviable tissue, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated at weekly intervals or for up to 10 applications.

Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant 18 years old or older
• Type I or Type II diabetes mellitus
• Participant has well controlled glucose levels, with HbA1c \< 12% within 3 months of Dermacyte Matrix application
• Participant has adequate lower extremity perfusion, with Ankle-Brachial Index \> 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high Ankle-Brachial Indices.) or dorsum transcutaneous oxygen test (TcPO2) \> 30 mmHg. The presence of tibial and plantar pulses is preferred.
• Willing and able to tolerate and maintain the required weight off-loading of the affected limb and perform necessary dressing changes
• DFU is full thickness (Wagner Grade I or II)
• Adults with a chronic non-healing DFU (at least 30 days but no longer than 52 weeks old) will be eligible for enrollment
• Participant's ulcer size \>0.5cm2 and \< 20cm2 area post-debridement
• Participant has plantar ulcers of greater than or equal to 4 weeks duration at presentation, unresponsive to standard wound care
• Participant should have no evidence of unresolved gross soft-tissue infection or boney pathology (i.e. osteomyelitis)
• Participant should have no evidence of underlying co-morbid conditions that would adversely affect wound healing such as: Cancer, Raynaud's syndrome, severe venous insufficiency or uncorrected arterial insufficiency, etc.
• Participant should not be on medications that compromise healing: cytotoxic chemotherapeutics, etc

You may not qualify if:

• Suspected or confirmed signs of infection of the study ulcer/limb including soft-tissue infection or osteomyelitis
• Subjects who are currently receiving, or have received within 4 weeks prior to study entry agents known to impair or affect wound healing, including:
• Adriamycin (doxorubicin), bleomycin, sirolimus (Rapamune, rapamycin) and anti-TNF cytotoxic/immunosuppressive agents;
• Radiation therapy at the ulcer site;
• Other immunosuppressive agents.
• Subjects presenting with:
• Charcot foot with a bony deformity
• Chopart's amputation
• Calcaneus ulcers
• Subjects previously treated with amniotic membrane or any other advanced therapy at the target site for 1 month prior to enrollment
• Subjects with evidence of skin cancer within or adjacent to the ulcer site.
• History of bone cancer of the affected limb
• Subjects who have significant arterial disease as determined by ABI, duplex Doppler sonography (PVR) or magnetic resonance angiography (MRA): Ankle-Brachial Index \< 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high ABIs); dorsum transcutaneous oxygen test (TcPO2) \< 30 mmHg; absence of tibial or plantar pulses.
• Subjects who have documented clinically significant medical conditions, which would impair wound healing. This includes:
• Renal impairment (creatinine \>2.5 mg/dL);

Sponsors & Collaborators

• Merakris Therapeutics: lead

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sean O'Connell, PhD

  Consultant

  STUDY DIRECTOR

Central Study Contacts

Travis C Jarrell, MS

CONTACT

301-905-6702; tcjarrell@milestoneregualtory.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 6, 2024
• Study Start: September 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share