A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Borate-based Bioactive Glass Advanced Wound Matrix and Standard of Care Versus Standard of Care Alone

ETS Wound Care, LLC14 sites in 1 country148 target enrollmentSeptember 13, 2022

ConditionsDiabetic Foot Ulcer Ulcer Foot Diabetic Foot

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: ETS Wound Care, LLC
Enrollment: 148
Locations: 14
Primary Endpoint: Complete Wound Healing
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.

Detailed Description

This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment. There are two arms in the study: Arm 1: SOC therapy (offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with resorbable bioactive glass fiber, MIRRAGEN™ Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent). ARM 2: SOC therapy (offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with calcium alginate Fibracol dressing follwed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

Registry

clinicaltrials.gov

Start Date

September 13, 2022

End Date

January 17, 2025

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ETS Wound Care, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must be at least 18 years of age or older.
•Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
•At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with a photographic planimetry app.
•The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
•The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
•The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
•Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
•TCOM ≥30 mmHg
•ABI between 0.7 and 1.3
•PVR: Biphasic

Exclusion Criteria

•A subject known to have a life expectancy of \< 6 months is excluded.
•If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
•Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
•A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
•A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
•The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
•A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
•If a subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.
•If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
•The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.