Clinical trial NCT03398538: Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
Official title: A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Ulcer Foot
Diabetic Foot
Keywords: DFU
Ulcer
Lead sponsor: ETS Wound Care, LLC
Sponsor class: INDUSTRY
Collaborators: name: Professional Education and Research Institute
First posted: 2018-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* At least 18 years old.
* Presence of a DFU, Wagner 1 (see Appendix B for definitions), extending at least through the dermis provided it is below the medial aspect of the malleolus.
* The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot they must be more than 2 cm distant from the index ulcer.
* Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1-year, as of the date the subject consents for study.
* Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
* Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a Toe Brachial Index (TBI) of \> 0.6 is acceptable.
* The target ulcer has been offloaded for at least 14 days prior to randomization.
* Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
* Subject understands and is willing to participate in the clinical study and can comply with weekly visits.

Exclusion Criteria:

* Index 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 immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
* Subjects taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.
* Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
* History of radiation at the ulcer site (regardless of time since last radiation treatment).
* Index ulcer has been previously treated or will need to be treated with any prohibited therapies. (See Section 7.3 of this protocol for a list of prohibited medications and therapies).
* 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 as verified by x-ray within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
* Subject is pregnant or breast-feeding.
* Presence of diabetes with poor metabolic control as documented with an HbA1c \> 12.0 within 90 days of randomization.
* Subjects with end stage renal disease as evidenced by a serum creatinine ≥ 3.0 mg/dL within 6 months of randomization.
* Index ulcer has reduced in area by 20% or more after 14 days of SOC from SV1 to the TV1/randomization visit.

Primary outcomes:
measure: Percentage of index ulcers healed at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of index ulcers healed at 6 weeks
timeFrame: 6 week
measure: Time to heal within 6 and 12 weeks
timeFrame: 6 and 12 weeks
measure: Percent Area Reduction (PAR) at 6 and 12 weeks
timeFrame: 6 and 12 weeks
measure: Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10"point discrimination test
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: Difference in cellulitis and/or infection at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Alan M Jacobs and Associates
state: Missouri
city: Youngstown
country: United States
facility: Lower Extremity Institute of Research and Therapy
state: Ohio
city: Martinsville
country: United States
facility: Martinsville Research Institute
state: Virginia
city: Roanoke
country: United States
facility: Professional Education and Research Institute
state: Virginia
city: Troutville
country: United States
facility: Shenandoah Lower Extremity Research Institute
state: Virginia
Study officials:
affiliation: USC / Salsa
name: David Armstrong, DPM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professional Education and Research Institute
name: Charles M Zelen, DPM
role: PRINCIPAL_INVESTIGATOR
References: