Diabetic Foot Clinical Trial
Official title:
Effectiveness of Supra SDRM® vs. Fibracol Plus Collagen in the Treatment of Diabetic Foot Ulcers: a Pilot Randomized Controlled Trial
Verified date | August 2023 |
Source | Polymedics Innovations Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 1, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. - 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. Exclusion Criteria: - 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. - 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 SDRMĀ®. - 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. |
Country | Name | City | State |
---|---|---|---|
United States | WAFL Inc | Circleville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Polymedics Innovations Inc. | McGill University |
United States,
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. — View Citation
Haller 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. — View Citation
Mirhaj 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to heal | Number of weeks required to achieve 100% epithelization of the wound | Up to 30 weeks | |
Primary | Healing by 12 weeks | Proportion of patients achieving 100% epithelization on or before week 12 | 12 weeks | |
Secondary | Direct costs | Direct costs of treatment | Up to 30 weeks | |
Secondary | Infection rate | Proportion of patients developing an infection in the wound bed | Up to 30 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06154915 -
Immune Cells in Diabetic Chronic Foot Ulcers
|
||
Completed |
NCT04624516 -
Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence
|
N/A | |
Not yet recruiting |
NCT06278935 -
Lifestyle Tailored Offloading for Diabetic Foot Ulcers
|
N/A | |
Completed |
NCT02373592 -
Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer
|
N/A | |
Active, not recruiting |
NCT01903044 -
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
|
Phase 1/Phase 2 | |
Completed |
NCT02092870 -
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
|
Phase 2 | |
Completed |
NCT01212120 -
The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
|
N/A | |
Completed |
NCT00402727 -
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
|
Phase 3 | |
Recruiting |
NCT04085705 -
The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
|
||
Completed |
NCT04054804 -
Digital Foot Check by Using the D-Foot, a New Software
|
||
Completed |
NCT04480801 -
The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer
|
N/A | |
Not yet recruiting |
NCT04537676 -
Patient Empowerment Study
|
||
Recruiting |
NCT04564443 -
A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
|
N/A | |
Recruiting |
NCT05974592 -
The Effect of Nurse-Led Diabetic Foot Self-Management Training Program
|
N/A | |
Not yet recruiting |
NCT04630795 -
ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
|
||
Not yet recruiting |
NCT05431660 -
Diabetic Foot School and Biomechanics
|
N/A | |
Completed |
NCT05101473 -
Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study
|
N/A | |
Completed |
NCT05123157 -
Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
|
||
Enrolling by invitation |
NCT05043636 -
Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
|
||
Completed |
NCT03254095 -
Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
|