Effect of Meso Wound Matrix in the Treatment of DFUs

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcers (DFUs)
• Interventions: Device: Meso Wound Matrix

• Registration Number: NCT04182451
• Lead Sponsor: SerenaGroup, Inc.

Brief Summary

This is a prospective trial designed to evaluate the use of Meso Wound Matrix (DSM Biomedical, Exton, PA) in Wagner grade 1 and 2 DFUs.

Detailed Description

At the Screening Visit (SV), written informed consent will be obtained from the subject by the Investigator or designee before the performance of any other protocol-specific procedure. The Investigator will select the Index (study) ulcer. Each subject will have only one DFU selected as the Index (study) ulcer. If the subject has more than one ulcer at the SV, the Investigator will select the largest ulcer that meets the eligibility criteria of the protocol as the Index (study) ulcer.The SV is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study. Those subjects who meet the eligibility criteria will transition to Treatment Visit 1 (TV1) on the same day as the SV.

Subjects who meet eligibility criteria at the SV will receive Meso Wound Matrix (DSM Biomedical, Exton, PA) and standard of care. During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using digital photographic planimetry. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subjects may receive up to eight applications of Meso Wound Matrix. Subjects whose study ulcer does not heal after eight applications will receive only SOC treatment for 4 additional weeks. Subjects whose ulcers do not achieve closure at or by 12 weeks or who experience an amputation will be deemed treatment failures.

Study Timeline

• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-12-02
• Study Start: 2019-12-05
• Primary Completion: 2022-05-17
• Study Completion: 2023-03-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. At least 18 years old
2. Presence of a diabetic foot ulcer, Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the tendon or muscle provided it is below the medial aspect of the malleolus
3. The index ulcer will be the largest ulcer if 2 or more ulcers are present on the same extremity. If other ulcerations are present on the same foot they must be more than 2 cm apart from the index ulcer.
4. Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit
5. Study ulcer size is a minimum of 0.75 cm2 and a maximum of 5 cm2 at first treatment visit
6. Adequate circulation to the affected extremity as demonstrated by a transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Brachial Index (ABI - measure of blood flow to the ankle) between 0.7 and ≤ 1.3
7. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
8. Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen
9. Subject has read and signed the IRB approved Informed Consent Form before screening procedures are undertaken
10. The subject is willing to apply a porcine based product to the wound

Exclusion Criteria

1. Study ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
2. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
3. 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 one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
4. History of radiation at the ulcer site.
5. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
6. Osteomyelitis or bone infection of the affected foot or leg as verified by X-ray within 30 days prior to Randomization.
7. Subject is pregnant or breast-feeding.
8. The study ulcer with a history of treatment with hyperbaric oxygen of cellular or Tissue-based Product (CTP) within 30 days of randomization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meso Wound Matrix and Standard of Care	Meso Wound Matrix	This is a single arm study

Primary Outcome Measures

Name	Time	Method
Efficacy of Meso Wound Matrix	12 Weeks	Efficacy of Meso Wound Matrix as an adjunctive treatment in facilitating wound healing in Wagner 1 and 2 grade DFUs when compared to traditional and well-established controls.

Secondary Outcome Measures

Name	Time	Method
Device Utilization	12 Weeks	Graft wastage
Health Economics	12 Weeks	Cost to heal
Wound Surface Area Reduction	4 Weeks	Proportion of wounds with surface area reduction of greater than 40% at 4 weeks
Wound Closure	12 Weeks	Proportion of wounds healed at 12 weeks
Adverse Events	12 Weeks	Incidence of adverse events

Trial Locations

Locations (3)

Royal Research; 🇺🇸 Pembroke Pines, Florida, United States

D&P Medical Group; 🇺🇸 Pittsburgh, Pennsylvania, United States

Foot & Ankle Wellness Clinic; 🇺🇸 Ford City, Pennsylvania, United States