CompletedNot Applicable

Effect of Meso Wound Matrix in the Treatment of DFUs

United States30 participantsStarted 2019-12-05

Plain-language 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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Efficacy of Meso Wound Matrix

Timeframe: 12 Weeks

NCT IDNCT04182451

SponsorSerenaGroup, Inc.

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2022-05-17

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.