Diabetic FootNCT05883098
SDRM® vs. Collagen for Diabetic Foot Ulcers
A study testing Wound debridement and Wound closure matrix application in people with Diabetic Foot and Ulcer Foot, run by Polymedics Innovations Inc. at 1 site in United States.
Trial summary
Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Ulcer Foot, Wound Heal
- What is being tested?
- Wound debridement and Wound closure matrix application
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 1 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 or older.
- Subject is willing to sign an informed consent and participate in all procedures and follow-up evaluations.
- Study ulcer is diabetic in origin, located on foot or below the malleolus (UT Grade 1A).
- Study ulcer size is a minimum of 2 cm2 and a maximum of 25 cm2.
- Study ulcer has been present for a minimum of 4 weeks before enrollment and less than 1 year old.
- Study ulcer has been offloaded for at least 14 days before randomization.
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- Subject does not exhibit clinical signs or symptoms of infection.
- Subject has adequate control of diabetes demonstrated by Hemoglobin A1c < 12% within 90 days of screening.
- Subject has adequate circulation to the affected extremity.
Who cannot join
- Study ulcer has > 40% wound healing during the 14 days screening period.
- Subject has a known history of poor compliance with medical treatments.
- Subject is presently participating in another clinical trial.
- Subject has a known or suspected local or systemic malignancy.
- Subject has been diagnosed with autoimmune connective tissues diseases.
- Subject has received graft material or topical growth factors on the study ulcer within the previous 30 days.
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- Subject has received application of topical steroids on the study ulcer surface within the previous 30 days.
- Subject is pregnant or breast feeding.
- Subject is on dialysis.
- Subject is taking medications that are considered immune system modulators or cytotoxic chemotherapies.
- Subject cannot be on systemic antibiotics prior to randomization, however, during the treatment phase infection management may include systemic antibiotics if in conjunction with debridement.
- Subject has a known allergy to ingredients/components of Supra SDRM®.
- Subject has osteomyelitis, and/or bony prominences present in the wound.
- Subject has ulcer probing to bone and tendon. (UT Grade II or III A-D).
- Subject is unable to comply with planned study procedures and treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Supra SDRM® vs. Fibracol Plus Collagen in the Treatment of Diabetic Foot Ulcers: a Pilot Randomized Controlled Trial
Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing. SUPRA SDRM® has 510k approval for partial and full-thickness wounds and has shown promising results in preliminary animal studies. The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with a commercially available dermal substitute, Supra SDRM®, as compared to an advanced standard of care (Fibracol Plus). Patient outcomes, including time to heal, healing by 12 weeks, direct costs, and infection rate, will be compared at the end of the study.
Read the detailed description
Chronic wounds are those that fail to proceed through the normal phases of wound healing. They pose a high risk for infection and risk complications resulting in amputation. A plethora of wound treatment modalities are commercially available to help improve patient outcomes. However, even when combined with a good standard of care practices and wound dressings, they may not be sufficient to promote timely wound closure. Cellular and/or tissue- based products (CTPs) may provide a healing advantage over traditional dressings. CTPs are derived from human (allograft), animal (xenograft), or synthetic materials or a combination thereof. CTPs can help encourage tissue repair or regeneration by providing scaffolds and the cells necessary to stimulate wound healing. Synthetic products may provide advantages over human or other animal sourced products because they are natural, non-biologic, avoid complications due to risk of disease transmission, and possess less immunologic potential.
The fully synthetic skin substitute evaluated in this study is SUPRA SDRM® Synthetic Biodegradable Matrix Wound Dressing (Polymedics Innovations Inc.; Woodstock,GA). The device is a novel synthetic, guided wound closure matrix, built as a bimodal foam membrane structure for the management of chronic wounds. It combines the benefits of a microporous structure that builds a protective barrier allowing the wound to heal and additional large pores which were created to enable ingrowth of blood vessels. This microenvironment initially provides a seal against contamination and modulates inflammation in wound bed. Subsequently, it supports cellular processes required for tissue repair and wound healing.
In this parallel randomized clinical trial, patients with diabetic foot ulcers grade UT 1A will receive either standard of care plus SUPRA SDRM or a collagen dressing (Fibracol Plus) weekly after wound debridement. Primary outcomes will be time to achieve wound healing, and the proportion of patients achieving healing by 12 weeks. Secondary outcomes will include the direct costs of treatment and the proportion of patients who developed infections during the trial.
- Conditions
- Diabetic Foot, Ulcer Foot, Wound Heal
- Being tested
- Wound debridement, Wound closure matrix application
- Keywords
- Diabetic foot ucer, Wound closure matrix, Wound healing, Chronic wound
- Medical subject headings
- Diabetic Foot, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound debridementProcedure or surgery
The study's wounds will be mechanically debrided before the experimental or active comparator devices are applied. Debridation will be performed by a trained clinician using a curette. Necrotic tissue and slough will be removed during this procedure.
Wound closure matrix applicationDevice
After wound debridement, the patients will receive the application of a wound closure matrix as dictated by their randomization allocation.
| Study group | Role | What they receive |
|---|---|---|
| SUPRA SDRM | Experimental | The subject will receive wound standard of care that will include Supra SDRM as an active synthetic wound closure matrix, covered with a non-adherent dressing plus an appropriate outer dressing to maintain moisture balance, then wrapped with stretch gauze and self-adherent wrap. Supra SDRM will be applied weekly, and the exterior dressings will be redressed as necessary.
Supra SDRM is FDA-cleared (K090160, K170213) for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds. It is commercialized as a single dermal substitute matrix for wound management. No preparation of SUPRA SDRM matrix is necessary. When applied to the wound SUPRA SDRM adheres well to the wound bed without the need for direct fixation. SUPRA SDRM becomes translucent after the application allowing healthcare professionals to easily assess the wound healing. SUPRA SDRM® is available in multiple sizes and can be trimmed to meet the patient's needs. Receives: Procedure: Wound debridement; Device: Wound closure matrix application |
| Fibracol Plus | Active comparator | The subject will receive wound standard of care that will include Fibracol Plus collagen dressing as an active synthetic wound closure matrix, covered with a non-adherent dressing plus an appropriate outer dressing to maintain moisture balance, then wrapped with stretch gauze and self-adherent wrap. Fibracol Plus collagen dressing will be applied weekly, and the exterior dressings will be redressed as necessary.
FIBRACOL™ Plus Collagen Wound Dressing with Alginate dressing contains more than just pure collagen. It's a soft, absorbent, and conformable wound dressing, composed of 90% collagen and 10% calcium alginate. In the presence of wound fluid, FIBRACOL™ Plus Dressing helps maintain a physiologically moist microenvironment at the wound surface. This environment supports granulation tissue formation, epithelialization and rapid wound healing. Receives: Procedure: Wound debridement; Device: Wound closure matrix application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to heal
Number of weeks required to achieve 100% epithelization of the wound
Measured: Up to 30 weeks
Healing by 12 weeks
Proportion of patients achieving 100% epithelization on or before week 12
Measured: 12 weeks
Secondary outcomes (2)
Direct costs
Direct costs of treatment
Measured: Up to 30 weeks
Infection rate
Proportion of patients developing an infection in the wound bed
Measured: Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jul 2022
- Primary completion31 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polymedics Innovations Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University
- Responsible party
- Sponsor
- Investigators
- Jose L Ramirez Garcia Luna, MD, PhD, Study chair, McGill UniversityBrock A Liden, DPM, Principal investigator, WAFL Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883098
- Sponsor's protocol ID
- PMI-SUPRASDRM®-01
- Status last verified
- Aug 2023
- First submitted
- 8 May 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.
PubMed 26339534Mirhaj M, Labbaf S, Tavakoli M, Seifalian AM. Emerging treatment strategies in wound care. Int Wound J. 2022 Nov;19(7):1934-1954. doi: 10.1111/iwj.13786. Epub 2022 Mar 17.
PubMed 35297170Haller HL, Sander F, Popp D, Rapp M, Hartmann B, Demircan M, Nischwitz SP, Kamolz LP. Oxygen, pH, Lactate, and Metabolism-How Old Knowledge and New Insights Might Be Combined for New Wound Treatment. Medicina (Kaunas). 2021 Nov 1;57(11):1190. doi: 10.3390/medicina57111190.
PubMed 34833408
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Supra SDRM® vs. Fibracol Plus Collagen in the Treatment of Diabetic Foot Ulcers: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05883098
- Acronym / sponsor ID
- PMI-SUPRASDRM®-01
- Conditions
- Diabetic Foot, Ulcer Foot, Wound Heal
- Keywords
- Diabetic foot ucer, Wound closure matrix, Wound healing, Chronic wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Polymedics Innovations Inc.Industry (pharma, biotech, devices)
- Collaborators
- McGill University
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 31 May 2023 (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.
Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing. SUPRA SDRM® has 510k approval for partial and full-thickness wounds and has shown promising results in preliminary animal studies. The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with a commercially available dermal substitute, Supra SDRM®, as compared to an advanced standard of care (Fibracol Plus). Patient outcomes, including time to heal, healing by 12 weeks, direct costs, and infection rate, will be compared at the end of the study.
Detailed description
Chronic wounds are those that fail to proceed through the normal phases of wound healing. They pose a high risk for infection and risk complications resulting in amputation. A plethora of wound treatment modalities are commercially available to help improve patient outcomes. However, even when combined with a good standard of care practices and wound dressings, they may not be sufficient to promote timely wound closure. Cellular and/or tissue- based products (CTPs) may provide a healing advantage over traditional dressings. CTPs are derived from human (allograft), animal (xenograft), or synthetic materials or a combination thereof. CTPs can help encourage tissue repair or regeneration by providing scaffolds and the cells necessary to stimulate wound healing. Synthetic products may provide advantages over human or other animal sourced products because they are natural, non-biologic, avoid complications due to risk of disease transmission, and possess less immunologic potential.
The fully synthetic skin substitute evaluated in this study is SUPRA SDRM® Synthetic Biodegradable Matrix Wound Dressing (Polymedics Innovations Inc.; Woodstock,GA). The device is a novel synthetic, guided wound closure matrix, built as a bimodal foam membrane structure for the management of chronic wounds. It combines the benefits of a microporous structure that builds a protective barrier allowing the wound to heal and additional large pores which were created to enable ingrowth of blood vessels. This microenvironment initially provides a seal against contamination and modulates inflammation in wound bed. Subsequently, it supports cellular processes required for tissue repair and wound healing.
In this parallel randomized clinical trial, patients with diabetic foot ulcers grade UT 1A will receive either standard of care plus SUPRA SDRM or a collagen dressing (Fibracol Plus) weekly after wound debridement. Primary outcomes will be time to achieve wound healing, and the proportion of patients achieving healing by 12 weeks. Secondary outcomes will include the direct costs of treatment and the proportion of patients who developed infections during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUPRA SDRM | Experimental | Procedure: Wound debridement, Device: Wound closure matrix applicationThe subject will receive wound standard of care that will include Supra SDRM as an active synthetic wound closure matrix, covered with a non-adherent dressing plus an appropriate outer dressing to maintain moisture balance, then wrapped with stretch gauze and self-adherent wrap. Supra SDRM will be applied weekly, and the exterior dressings will be redressed as necessary. Supra SDRM is FDA-cleared (K090160, K170213) for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds. It is commercialized as a single dermal substitute matrix for wound management. No preparation of SUPRA SDRM matrix is necessary. When applied to the wound SUPRA SDRM adheres well to the wound bed without the need for direct fixation. SUPRA SDRM becomes translucent after the application allowing healthcare professionals to easily assess the wound healing. SUPRA SDRM® is available in multiple sizes and can be trimmed to meet the patient's needs. |
| Fibracol Plus | Active comparator | Procedure: Wound debridement, Device: Wound closure matrix applicationThe subject will receive wound standard of care that will include Fibracol Plus collagen dressing as an active synthetic wound closure matrix, covered with a non-adherent dressing plus an appropriate outer dressing to maintain moisture balance, then wrapped with stretch gauze and self-adherent wrap. Fibracol Plus collagen dressing will be applied weekly, and the exterior dressings will be redressed as necessary. FIBRACOL™ Plus Collagen Wound Dressing with Alginate dressing contains more than just pure collagen. It's a soft, absorbent, and conformable wound dressing, composed of 90% collagen and 10% calcium alginate. In the presence of wound fluid, FIBRACOL™ Plus Dressing helps maintain a physiologically moist microenvironment at the wound surface. This environment supports granulation tissue formation, epithelialization and rapid wound healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females aged 18 or older.
- Subject is willing to sign an informed consent and participate in all procedures and follow-up evaluations.
- Study ulcer is diabetic in origin, located on foot or below the malleolus (UT Grade 1A).
- Study ulcer size is a minimum of 2 cm2 and a maximum of 25 cm2.
- Study ulcer has been present for a minimum of 4 weeks before enrollment and less than 1 year old.
Key exclusion criteria (15 listed)
- Study ulcer has > 40% wound healing during the 14 days screening period.
- Subject has a known history of poor compliance with medical treatments.
- Subject is presently participating in another clinical trial.
- Subject has a known or suspected local or systemic malignancy.
- Subject has been diagnosed with autoimmune connective tissues diseases.
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 |
|---|---|---|
| Wound debridementThe study's wounds will be mechanically debrided before the experimental or active comparator devices are applied. Debridation will be performed by a trained clinician using a curette. Necrotic tissue and slough will be removed during this procedure. | Procedure or surgery | Fibracol Plus, SUPRA SDRM |
| Wound closure matrix applicationAfter wound debridement, the patients will receive the application of a wound closure matrix as dictated by their randomization allocation. | Device | Fibracol Plus, SUPRA SDRM |
Primary outcome
Time to heal
Time frame: Up to 30 weeks
Number of weeks required to achieve 100% epithelization of the wound
Healing by 12 weeks
Time frame: 12 weeks
Proportion of patients achieving 100% epithelization on or before week 12
2 secondary outcomes
Direct costs
Time frame: Up to 30 weeks
Infection rate
Time frame: Up to 30 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 28 Aug 2023.
- Background: PubMed 26339534Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.
- Background: PubMed 35297170Mirhaj M, Labbaf S, Tavakoli M, Seifalian AM. Emerging treatment strategies in wound care. Int Wound J. 2022 Nov;19(7):1934-1954. doi: 10.1111/iwj.13786. Epub 2022 Mar 17.
- Background: PubMed 34833408Haller HL, Sander F, Popp D, Rapp M, Hartmann B, Demircan M, Nischwitz SP, Kamolz LP. Oxygen, pH, Lactate, and Metabolism-How Old Knowledge and New Insights Might Be Combined for New Wound Treatment. Medicina (Kaunas). 2021 Nov 1;57(11):1190. doi: 10.3390/medicina57111190.
- Individual participant dataSharing planned: No
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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.
Jose L Ramirez Garcia Luna, MD, PhD study chair
McGill University
Brock A Liden, DPM principal investigator
WAFL Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound debridement and Wound closure matrix application in people with Diabetic Foot and Ulcer Foot, run by Polymedics Innovations Inc. at 1 site 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 15 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 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Time to heal (time frame: Up to 30 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883098, which also lists 3 linked publications.
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 28 Aug 2023.