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Effect of Meso Wound Matrix in the Treatment of DFUs

Primary Purpose

Diabetic Foot Ulcers (DFUs)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Meso Wound Matrix

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers (DFUs) focused on measuring Chronic wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Royal Research
Foot & Ankle Wellness Clinic
D&P Medical Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meso Wound Matrix and Standard of Care

Arm Description

This is a single arm study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Wound Surface Area Reduction

Proportion of wounds with surface area reduction of greater than 40% at 4 weeks

Wound Closure

Proportion of wounds healed at 12 weeks

Adverse Events

Incidence of adverse events

Device Utilization

Graft wastage

Health Economics

Cost to heal

Full Information

NCT ID

NCT04182451

First Posted

November 27, 2019

Last Updated

April 25, 2023

Sponsor

SerenaGroup, Inc.

Collaborators

DSM Biomedical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04182451

Brief Title

Effect of Meso Wound Matrix in the Treatment of DFUs

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).

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

December 5, 2019 (Actual)

Primary Completion Date

May 17, 2022 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SerenaGroup, Inc.

Collaborators

DSM Biomedical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcers (DFUs)

Keywords

Chronic wounds

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Meso Wound Matrix and Standard of Care

Arm Type

Experimental

Arm Description

This is a single arm study

Intervention Type

Device

Intervention Name(s)

Meso Wound Matrix

Intervention Description

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 Measure Information:

Title

Efficacy of Meso Wound Matrix

Description

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.

Time Frame

12 Weeks

Secondary Outcome Measure Information:

Title

Wound Surface Area Reduction

Description

Proportion of wounds with surface area reduction of greater than 40% at 4 weeks

Time Frame

4 Weeks

Title

Wound Closure

Description

Proportion of wounds healed at 12 weeks

Time Frame

12 Weeks

Title

Adverse Events

Description

Incidence of adverse events

Time Frame

12 Weeks

Title

Device Utilization

Description

Graft wastage

Time Frame

12 Weeks

Title

Health Economics

Description

Cost to heal

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Facility Information:

Facility Name

Royal Research

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33027

Country

United States

Facility Name

Foot & Ankle Wellness Clinic

City

Ford City

State/Province

Pennsylvania

ZIP/Postal Code

16226

Country

United States

Facility Name

D&P Medical Group

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15237

Country

United States

12. IPD Sharing Statement

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Effect of Meso Wound Matrix in the Treatment of DFUs

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