An interventional study of Offloading and Additional (outer) Dressing Application in Diabetic Foot Ulcer, Ulcer Foot and Diabetic Foot, sponsored by ETS Wound Care, LLC. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by ETS Wound Care, LLC · Not applicable, Interventional, and Treatment
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC dressings treatments for Diabetic Foot Wounds
This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available SOC 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 standard of care arms in the study:
Arm 1: The SOC therapy in this study is 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 bioactive resorbable glass fiber dressing, 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: The SOC therapy in this study is 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 followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).
Exclusion Criteria:
MIRRAGEN™ Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix dressing to be used per manufacturer instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing
Other: Offloading · Other: Additional (outer) Dressing Application · Other: Mirragen Wound Matrix Dressing
A commercially available wound dressing to be used per manufacturer's instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing
Other: Offloading · Other: Additional (outer) Dressing Application · Other: Fibracol Wound Dressing
Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
Also known as: Pressure relief
Application of outer a moisture retentive dressing, and a multi-layer compression dressing.
Also known as: Outer protective dressing
Application of Mirragen to wound site along with standard of care treatment
Application of Fibracol Alginate along with standard of care treatment
Percentage of index ulcers healed at 12 weeks
examine percent of ulcers healed at week twelve
Time frame: 12 weeks
Percentage of index ulcers healed at 6 weeks
examine percent of ulcers healed at week six
Time frame: 6 week
Time to heal within 6 and 12 weeks
examine time to healing at both six and twelve weeks
Time frame: 6 and 12 weeks
Percent Area Reduction (PAR) at 6 and 12 weeks
examine PAR at both six and twelve weeks
Time frame: 6 and 12 weeks
Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10"point discrimination test
Each clinical trial participant will be examined by the principal investigator with a Semmes Weinstein monofilament wire at 10 points on the study foot, this standardized exam will be scored out of a total of 10 at each visit and recorded
Time frame: 12 weeks
Changes in wound quality of life, the " Wound Quality of Life Questionnaire" will be given to the clinical trial participants and administered during each visit
The Wound-QoL, or wound quality of life questionnaire, measures the disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which are always assessed in retrospect to the preceding seven days. This questionnaire will be given to clinical trial participants at each visit, with the scale scores recorded. Each question is scored. Answers to each item are coded with numbers (0='not at all' to 4='very much'). As noted above the score will be reported with a minimam score of "0" and a maximum score of 68
Time frame: 12 weeks
Change in pain levels during trial, using the FACES pain scales which measure pain on a range of 0-10, zero being no pain and 10 being the most severe pain
The FACES pain scale will be administered to the clinical trial participants at each visit. The trial participant will select their pain level with a series of faces that correspond to a number between 0 which implies no pain , up to 10 which implies the most severe pain. The scores will be recorded for each clinical trial participant on each visit
Time frame: 12 weeks
Difference in cellulitis and/or infection at 12 weeks
Examine difference in infection rate over twelve weeks
Time frame: 12 weeks
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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