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

A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix for the Treatment of Diabetic Foot Ulcers (DFU)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Dermacyte Matrix; Other: Standard of Care (SOC)

Detailed Description

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 standard of care (SOC).

Part 1 of the study will enroll 20 participants to determine the percentage of participants with a complete ulcer closure following treatment with Dermacyte Matrix at Week 12.

In Part 2 of the study approximately 65 participants will be randomized 1:1 to receive Dermacyte Matrix or SOC for 12 weeks. The final sample size for Part 2 may be adjusted based on the effect size observed in Part 1 of the study.

For the purposes of this study, 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.

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Travis C Jarrell, MS; Phone Number: 301-905-6702; Email: tcjarrell@milestoneregualtory.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant 18 years old or older
2. Type I or Type II diabetes mellitus
3. Participant has well controlled glucose levels, with HbA1c < 12% within 3 months of Dermacyte Matrix application
4. 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.
5. Willing and able to tolerate and maintain the required weight off-loading of the affected limb and perform necessary dressing changes
6. DFU is full thickness (Wagner Grade I or II)
7. Adults with a chronic non-healing DFU (at least 30 days but no longer than 52 weeks old) will be eligible for enrollment
8. Participant's ulcer size >0.5cm2 and < 20cm2 area post-debridement
9. Participant has plantar ulcers of greater than or equal to 4 weeks duration at presentation, unresponsive to standard wound care
10. Participant should have no evidence of unresolved gross soft-tissue infection or boney pathology (i.e. osteomyelitis)
11. 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.
12. Participant should not be on medications that compromise healing: cytotoxic chemotherapeutics, etc

Exclusion Criteria:

1. Suspected or confirmed signs of infection of the study ulcer/limb including soft-tissue infection or osteomyelitis

2. Subjects who are currently receiving, or have received within 4 weeks prior to study entry agents known to impair or affect wound healing, including:

   1. Adriamycin (doxorubicin), bleomycin, sirolimus (Rapamune, rapamycin) and anti-TNF cytotoxic/immunosuppressive agents;
   2. Radiation therapy at the ulcer site;
   3. Other immunosuppressive agents.

3. Subjects presenting with:

   1. Charcot foot with a bony deformity
   2. Chopart's amputation
   3. Calcaneus ulcers
4. Subjects previously treated with amniotic membrane or any other advanced therapy at the target site for 1 month prior to enrollment
5. Subjects with evidence of skin cancer within or adjacent to the ulcer site.
6. History of bone cancer of the affected limb
7. 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.

8. Subjects who have documented clinically significant medical conditions, which would impair wound healing. This includes:

   1. Renal impairment (creatinine >2.5 mg/dL);
   2. Hepatic impairment (2XULN);
   3. Hematological disorders (abnormities of formed elements);
   4. Neurologic disorders resulting in significant impairment of sensory and motor functions as judged by the investigator;
   5. Excessive lymphedema that could interfere with wound healing
   6. Subjects with signs and symptoms of cellulitis;
   7. Subjects with ulcers with sinus tracts associated with an ongoing infection;
   8. Subjects with active deep vein thrombosis;
   9. Subjects with uncontrolled diabetes, as demonstrated by increased HbA1C (> 12%);
   10. Immunocompromised subjects (e.g., lymphoma, AIDS, myelodysplastic disorders)
9. HBOT within 3 days of treatment visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dermacyte Matrix; 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; 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.
Other: Standard of Care; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the safety of Dermacyte Matrix compared to SOC	Safety will be assessed throughout the study. Adverse events will be recorded using the NCI Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5).	12 weeks
To determine the heal rate of DFU for Dermacyte Matrix and SOC	Healing rate will be assessed by percent area reduction of the target ulcer from Baseline to Week 12.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure change in quality of life (QoL)	QoL will be assessed at Baseline and Week 12 via patient reported outcomes using the Neuro-QoL (Quality of Life in Neurological Disorders); a disease-specific instrument that has been validated for assessing the impact of peripheral neuropathy and foot ulceration and quality of life in patients with diabetes.	12 weeks

Collaborators and Investigators

• Sponsor: Merakris Therapeutics
• Investigators: Study Director: Sean O'Connell, PhD, Consultant

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: DM-DFU-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No