Diabetic Foot UlcerNCT03398538
Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
A study testing Offloading, Additional (outer) Dressing Application and Mirragen Wound Matrix Dressing in people with Diabetic Foot Ulcer and Ulcer Foot, run by ETS Wound Care, LLC at 5 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- What is being tested?
- Offloading, Additional (outer) Dressing Application and Mirragen Wound Matrix Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 Dec 2017to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Martinsville Research Institute
Martinsville, Virginia, 23116
Professional Education and Research Institute
Roanoke, Virginia, 24016
Alan M Jacobs and Associates
St Louis, Missouri, 63117
Shenandoah Lower Extremity Research Institute
Troutville, Virginia, 24019
Lower Extremity Institute of Research and Therapy
Youngstown, Ohio, 44512
About this study
Official title: A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
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
Read the 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).
- Conditions
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- Being tested
- Offloading, Additional (outer) Dressing Application, Mirragen Wound Matrix Dressing, Fibracol Wound Dressing
- Keywords
- DFU, Ulcer
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OffloadingOther
Also called Pressure relief
Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
Additional (outer) Dressing ApplicationOther
Also called Outer protective dressing
Application of outer a moisture retentive dressing, and a multi-layer compression dressing.
Mirragen Wound Matrix DressingOther
Application of Mirragen to wound site along with standard of care treatment
Fibracol Wound DressingOther
Application of Fibracol Alginate along with standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Mirragen Wound Matrix Dressing | Experimental | 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 Receives: Other: Offloading; Other: Additional (outer) Dressing Application; Other: Mirragen Wound Matrix Dressing |
| Fibracol Wound Dressing | Active comparator | 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 Receives: Other: Offloading; Other: Additional (outer) Dressing Application; Other: Fibracol Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of index ulcers healed at 12 weeks
examine percent of ulcers healed at week twelve
Measured: 12 weeks
Secondary outcomes (7)
Percentage of index ulcers healed at 6 weeks
examine percent of ulcers healed at week six
Measured: 6 week
Time to heal within 6 and 12 weeks
examine time to healing at both six and twelve weeks
Measured: 6 and 12 weeks
Percent Area Reduction (PAR) at 6 and 12 weeks
examine PAR at both six and twelve weeks
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Difference in cellulitis and/or infection at 12 weeks
Examine difference in infection rate over twelve weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start26 Dec 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETS Wound Care, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Responsible party
- Sponsor
- Investigators
- David Armstrong, DPM, MD, PhD, Principal investigator, USC / SalsaCharles M Zelen, DPM, Principal investigator, Professional Education and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398538
- Sponsor's protocol ID
- ETS-MG-01
- Status last verified
- Aug 2022
- First submitted
- 3 Jan 2018
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03398538
- Acronym / sponsor ID
- ETS-MG-01
- Conditions
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- Keywords
- DFU, Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ETS Wound Care, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
| Arm | Type | Receives |
|---|---|---|
| Mirragen Wound Matrix Dressing | Experimental | Other: Offloading, Other: Additional (outer) Dressing Application, Other: Mirragen Wound Matrix DressingMIRRAGEN™ 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 |
| Fibracol Wound Dressing | Active comparator | Other: Offloading, Other: Additional (outer) Dressing Application, Other: Fibracol Wound DressingA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OffloadingAlso: Pressure reliefPatient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot | Other | Fibracol Wound Dressing, Mirragen Wound Matrix Dressing |
| Additional (outer) Dressing ApplicationAlso: Outer protective dressingApplication of outer a moisture retentive dressing, and a multi-layer compression dressing. | Other | Fibracol Wound Dressing, Mirragen Wound Matrix Dressing |
| Mirragen Wound Matrix DressingApplication of Mirragen to wound site along with standard of care treatment | Other | Mirragen Wound Matrix Dressing |
| Fibracol Wound DressingApplication of Fibracol Alginate along with standard of care treatment | Other | Fibracol Wound Dressing |
Primary outcome
Percentage of index ulcers healed at 12 weeks
Time frame: 12 weeks
examine percent of ulcers healed at week twelve
7 secondary outcomes
Percentage of index ulcers healed at 6 weeks
Time frame: 6 week
Time to heal within 6 and 12 weeks
Time frame: 6 and 12 weeks
Percent Area Reduction (PAR) at 6 and 12 weeks
Time frame: 6 and 12 weeks
Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10"point discrimination test
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
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
Time frame: 12 weeks
Difference in cellulitis and/or infection at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Armstrong, DPM, MD, PhD principal investigator
USC / Salsa
Charles M Zelen, DPM principal investigator
Professional Education and Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offloading, Additional (outer) Dressing Application and Mirragen Wound Matrix Dressing in people with Diabetic Foot Ulcer and Ulcer Foot, run by ETS Wound Care, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of index ulcers healed at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.