Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

Not Applicable

Recruiting

• Conditions: Diabetic Foot; Diabetic Foot Ulcer; Ulcer Foot
• Interventions: Device: Mirragen Wound Matrix; Device: Fibracol

• Registration Number: NCT06403605
• Lead Sponsor: ETS Wound Care, LLC

Brief Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC 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, 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 the 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 follwed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

Study Timeline

• Study Start: 2022-08-29
• Status Verified: 2023-05
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Subjects must be at least 18 years of age or older.

2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.

3. 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.

4. 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.

5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.

6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone.

7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:

   1. TCOM ≥30 mmHg
   2. ABI between 0.7 and 1.3
   3. PVR: Biphasic
   4. TBI ˃0.6
   5. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle

8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.

9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.

10. The subject must consent to using the prescribed off-loading method for the duration of the study.

11. The subject must agree to attend the weekly study visits required by the protocol.

12. The subject must be willing and able to participate in the informed consent process.

Exclusion Criteria

1. A subject known to have a life expectancy of < 6 months is excluded.
2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
4. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
7. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
8. 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.
9. If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
10. 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.
11. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
12. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
13. A potential subject with end stage renal disease requiring dialysis is excluded.
14. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days is excluded.
15. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
16. A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOC primary dressing with MIRRAGEN™	Mirragen Wound Matrix	Mirragen Wound Matrix MIRRAGEN™ Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix 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
SOC primary dressing with FIBRACOL™	Fibracol	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

Primary Outcome Measures

Name	Time	Method
Percentage of index ulcers healed at 12 weeks	12 weeks	The proportion of subjects that obtain complete closure over the 12- week treatment period

Secondary Outcome Measures

Name	Time	Method
Percent wound area reduction (PAR)	6 and 12 weeks	Percentage wound area reduction from TV1 to TV13 measured weekly with digital photographic planimetry and physical examination
Changes in wound quality of life using Wound-Q	12 weeks	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='note at all' to 4='very much'). As noted above the score will be reported with a minimum score of "0" and a maximum score of 68. (week 1, 3, 7, 9, 12)
Number and type of SAE	12 weeks	The number and type of treatment emergent adverse and serious adverse events
Change in pain levels during trial, using the NPRS pain scale which measure pain on a range of 0-10, zero being no pain and 10 being the most severe pain	12 weeks	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 to achieve complete wound closure	12 weeks	The time to achieve complete wound closure of the target ulcer by the end of 12 weeks
Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10" point discrimination test	12 weeks	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. (week 1, 3, 7, 9, 12)

Trial Locations

Locations (14)

LA Foot and Ankle; 🇺🇸 Los Angeles, California, United States

Doctor's Research Network; 🇺🇸 South Miami, Florida, United States

Foot and Ankle Specialists of the Mid Atlantic; 🇺🇸 Salem, Virginia, United States

Gateway Clinical Trials; 🇺🇸 O'Fallon, Illinois, United States

United Wound Healing P.S; 🇺🇸 Auburn, Washington, United States

Casa Colina; 🇺🇸 Pomona, California, United States

Wound Centrics; 🇺🇸 Corpus Christi, Texas, United States

Center for Clincal Research; 🇺🇸 San Francisco, California, United States

Lower Extremity Institute for Research and Therapy; 🇺🇸 Youngstown, Ohio, United States

Foot and Ankle Center of Illinois; 🇺🇸 Springfield, Illinois, United States

Mercy Medical Center; 🇺🇸 Cedar Rapids, Iowa, United States

Southernmost Foot and Ankle Specialists; 🇺🇸 Homestead, Florida, United States

Wound Care Experts; 🇺🇸 Las Vegas, Nevada, United States

PULSE: Amputation Prevention Center, LLC; 🇺🇸 El Paso, Texas, United States