Effect of Meso Wound Matrix in the Treatment of DFUs

NCT04182451 | Completed FDA Device

• 1 other identifier: MESO-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetic Foot Ulcers (DFUs)

Keywords

Chronic wounds

Outcome Measures

Primary Outcomes (1)

• Efficacy of Meso Wound Matrix

  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.

  12 Weeks

Secondary Outcomes (5)

• Wound Surface Area Reduction

  4 Weeks

• Wound Closure

  12 Weeks

• Adverse Events

  12 Weeks

• Device Utilization

  12 Weeks

• Health Economics

  12 Weeks

Study Arms (1)

Meso Wound Matrix and Standard of Care

EXPERIMENTAL

This is a single arm study

Device: Meso Wound Matrix

Interventions

Meso Wound Matrix DEVICE

Subjects who meet eligibility criteria will receive standard of care and Meso Wound Matrix. The standard of care therapy in this study is offloading of the DFU, appropriate sharp or surgical debridement, and aggressive infection management with the use of appropriate dressings. Total contact casting or fixed ankle walker will be used for off-loading. Wound Matrix is an acellular scaffold to reinforce and repair soft tissue defects. 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.

Meso Wound Matrix and Standard of Care

Eligibility Criteria

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

You may qualify if:

• At least 18 years old
• 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
• 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.
• Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit
• Study ulcer size is a minimum of 0.75 cm2 and a maximum of 5 cm2 at first treatment visit
• 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
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen
• Subject has read and signed the IRB approved Informed Consent Form before screening procedures are undertaken
• The subject is willing to apply a porcine based product to the wound

You may not qualify if:

• Study ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
• 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.
• 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.
• History of radiation at the ulcer site.
• 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.
• Osteomyelitis or bone infection of the affected foot or leg as verified by X-ray within 30 days prior to Randomization.
• Subject is pregnant or breast-feeding.
• The study ulcer with a history of treatment with hyperbaric oxygen of cellular or Tissue-based Product (CTP) within 30 days of randomization.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• DSM Biomedical, Inc.: collaborator

Study Sites (3)

Royal Research

Pembroke Pines, Florida, 33027, United States

Location

Foot & Ankle Wellness Clinic

Ford City, Pennsylvania, 16226, United States

Location

D&P Medical Group

Pittsburgh, Pennsylvania, 15237, United States

Location

MeSH Terms

Conditions

Diabetic Foot

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: December 5, 2019
• Primary Completion: May 17, 2022
• Study Completion: March 1, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

US (3)