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Effect of Meso Wound Matrix in the Treatment of DFUs

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ClinicalTrials.gov Identifier: NCT04182451
Recruitment Status : Not yet recruiting
First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
DSM Biomedical, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers (DFUs) Device: Meso Wound Matrix Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Prospective Clinical Trial Evaluating the Effect of Meso Wound Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs).
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meso Wound Matrix and Standard of Care
This is a single arm study
Device: Meso Wound Matrix

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.





Primary Outcome Measures :
  1. Efficacy of Meso Wound Matrix [ Time Frame: 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 :
  1. Wound Surface Area Reduction [ Time Frame: 4 Weeks ]
    Proportion of wounds with surface area reduction of greater than 40% at 4 weeks

  2. Wound Closure [ Time Frame: 12 Weeks ]
    Proportion of wounds healed at 12 weeks

  3. Adverse Events [ Time Frame: 12 Weeks ]
    Incidence of adverse events

  4. Device Utilization [ Time Frame: 12 Weeks ]
    Graft wastage

  5. Health Economics [ Time Frame: 12 Weeks ]
    Cost to heal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182451


Contacts
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Contact: Thomas Serena, MD 617-945-5225 serena@serenagroups.com

Locations
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United States, Florida
Royal Research Not yet recruiting
Pembroke Pines, Florida, United States, 33027
Contact: Yalily Perez    954-940-0208    yalilyp@royalresearchcorp.com   
Principal Investigator: Neal Bullock, DPM         
United States, Pennsylvania
Foot & Ankle Wellness Clinic Not yet recruiting
Ford City, Pennsylvania, United States, 16226
Contact: Nicole Schrecengost    724-763-4080    nschrecengost@serenagroups.com   
Principal Investigator: Matthew Sabo, DPM         
D&P Medical Group Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: Laura Serena    412-335-0764    lserena@serenagroups.com   
Principal Investigator: Bryan Doner, DO         
Sub-Investigator: Keyur Patel, DO         
Sponsors and Collaborators
SerenaGroup, Inc.
DSM Biomedical, Inc.

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Responsible Party: SerenaGroup, Inc.
ClinicalTrials.gov Identifier: NCT04182451     History of Changes
Other Study ID Numbers: MESO-001
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by SerenaGroup, Inc.:
Chronic wounds
Additional relevant MeSH terms:
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Diabetes Complications
Diabetes Mellitus
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases