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BACKGROUND: The diabetic foot ulcer presents a therapeutic challenge with a high rate of limb infection and extremity amputation. Adequate debridement and stable coverage of exposed structures is paramount to preserving limb length. We reviewed our use of a collagen bilayer matrix in the diabetic population for the preservation of functional limb length. Salvage rates were stratified with patient comorbidities of severe peripheral arterial disease and/or persistent infection.
METHODS: A retrospective review was performed of all consecutive patients that underwent application of Integra by the senior authors (JSS, CEA) for lower extremity salvage between January 2004 and December 2008.
RESULTS: 105 patients with 121 separate wounds were analyzed. Patients ranged from 22 to 80 (mean 58) years-old, and the average wound size was 25.9 cm in the diabetic population. Average follow up was 325 days, and average number of operations pre-closure was 1.28. In the diabetic population, of the 59 patients identified as low-risk for amputation, 10 (17%) progressed to amputation. Of the 28 patients identified as high-risk for amputation, 15 (54%) progressed to amputation. In the non-diabetics, 31 patients were classified as low-risk for amputation, and 1 (3%) went on to an amputation.
CONCLUSIONS: The use of a collagen bilayer matrix appears to be a viable option for reconstruction and stable closure in the diabetic patient at low-risk for amputation, with risk based on available blood supply and evidence of infection. However, in the diabetic patient at high-risk for amputation, the rate of salvage may not be improved with the use of Integra.
Re: The Use of a Collagen Bilayer Matrix and Risk Factors for Amputation
Ease of Use, Safety, and Efficacy of Integra Bilayer Wound Matrix in the Treatment of Diabetic Foot Ulcers in an Outpatient Clinical Setting
A Prospective Pilot Study
Min Yao, Khaled Attalla, Yanhan Ren, Michael A. French, Vickie R. Driver J Am Podiatr Med Assoc 103(4): 274–280, 2013
Background: Integra bilayer wound matrix (IBWM) is a bilayer skin replacement system composed of a dermal regeneration layer and a temporary epidermal layer. It is used to treat various types of deep, large wounds via an inpatient procedure in an operating room. We sought to determine ease of use and effectiveness of IBWM in an outpatient clinical setting when treating diabetic foot ulcers. In addition, no epidermal autografting was performed in conjunction with the IBWM after silicone release, as is common in the inpatient setting.
Methods: This 12-week, single-arm, prospective pilot study was conducted in three outpatient clinics. Weekly evaluations included monitoring the wound for signs of infection during the 12-week follow-up phase.
Results: Eleven patients with diabetic foot ulcers who met the inclusion and exclusion criteria were enrolled. One patient was discontinued from the study owing to noncompliance leading to a serious adverse event. Therefore, ten patients who received the study intervention were included in the per-protocol population reported herein. The mean patient age was 60.6 years, with an average 11-year history of diabetes mellitus. Each ulcer was located on the plantar aspect of the foot. No infection was reported during the study. Patients treated with IBWM showed progressive wound healing over time: the greatest mean wound reduction was approximately 95% in week 12. Seven of ten patients (70%) achieved complete wound closure by week 12. No recurrent ulcers were reported during follow-up.
Conclusions: These results are consistent with the hypothesis that IBWM is easy to use, safe, and effective when used on diabetic foot ulcers in an outpatient clinical setting without the secondary procedure of autografting for closure.
Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra? Dermal Regeneration Template (IDRT) for the treatment of non-healing DFUs. The FOot Ulcer New DErmal Replacement (FOUNDER) Study was a multi-center, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption (IDE). Thirty-two sites enrolled and randomized 307 subjects with at least one DFU. Consented patients were entered into the 14-day run-in phase where they were treated with the standard of care (0.9% sodium chloride gel) plus a secondary dressing and an offloading/protective device. Patients with less than 30% re-epithelialization of the study ulcer after the run-in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9% sodium chloride gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100% re-epithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p=0.001) at sixteen weeks. The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2% per week for IDRT subjects versus 4.8% per week for control subjects (p=0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared to the standard of care treatment. IDRT could greatly enhance the treatment of non-healing DFUs
Re: The Use of a Collagen Bilayer Matrix and Risk Factors for Amputation
FDA News Release FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers
January 7, 2016
The U.S. Food and Drug Administration today approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.
An estimated 29 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention, and about 25 percent of them will experience a foot ulcer during their lifetime. Chronic diabetic foot ulcers are associated with tissue and bone infections and result in 50,000 amputations each year.
“We are excited to see a new innovation in diabetes care with the potential to improve the number of foot ulcers that heal,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Healing of these painful and debilitating ulcers is essential for patients to resume walking and other daily activities.”
The FDA first approved Integra Dermal Regeneration Template (which the company now also calls Omnigraft) in 1996 for the treatment of life threatening burn injuries when the use of a patient’s own skin for a graft was not possible. In 2002, Integra Dermal Regeneration Template was approved for a new indication to treat patients undergoing reconstructive surgery for burn scars when they cannot have skin grafts. Now, Omnigraft is approved to treat certain diabetic foot ulcers that last for longer than six weeks and do not involve exposure of the joint capsule, tendon or bone, when used in conjunction with standard diabetic ulcer care.
Omnigraft’s new indication is based on a clinical study that demonstrated that the matrix device improved ulcer healing compared to standard diabetic foot ulcer care, which includes cleaning and covering the wound with a surgical bandage and keeping weight off of the foot with the ulcer. In the study, 51 percent of patients treated with Omnigraft had healed ulcers after 16 weeks compared to 32 percent of patients treated with standard diabetic foot ulcer care alone.
Adverse events observed in the clinical trial included infections, increased pain, swelling, nausea, and new or worsening ulcers.
Omnigraft shouldnot be used in patients with allergies to cow (bovine) collagen or chondroitin (cartilage from any source) since serious allergic reactions may occur. Omnigraft should also not be used on infected wounds.
Omnigraft is manufactured by Integra LifeSciences Corporation of Plainsboro, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.