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
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers (DFUs)||Device: Meso Wound Matrix||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Wound Surface Area Reduction [ Time Frame: 4 Weeks ]Proportion of wounds with surface area reduction of greater than 40% at 4 weeks
- Wound Closure [ Time Frame: 12 Weeks ]Proportion of wounds healed at 12 weeks
- Adverse Events [ Time Frame: 12 Weeks ]Incidence of adverse events
- Device Utilization [ Time Frame: 12 Weeks ]Graft wastage
- Health Economics [ Time Frame: 12 Weeks ]Cost to heal
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
|Contact: Thomas Serena, MDfirstname.lastname@example.org|
|United States, Florida|
|Pembroke Pines, Florida, United States, 33027|
|Contact: Yalily Perez 954-940-0208 email@example.com|
|Principal Investigator: Neal Bullock, DPM|
|United States, Pennsylvania|
|Foot & Ankle Wellness Clinic|
|Ford City, Pennsylvania, United States, 16226|
|Contact: Nicole Schrecengost 724-763-4080 firstname.lastname@example.org|
|Principal Investigator: Matthew Sabo, DPM|
|D&P Medical Group|
|Pittsburgh, Pennsylvania, United States, 15237|
|Contact: Laura Serena 412-335-0764 email@example.com|
|Principal Investigator: Bryan Doner, DO|
|Sub-Investigator: Keyur Patel, DO|