Randomized Clinical Trial Comparing OASIS Wound Matrix to Regranex Gel for Diabetic Ulcers

Niezgoda, Jeffrey A.; Gils, Carl C Van; Frykberg, Robert G.; Hodde, Jason P.

doi:10.1097/00129334-200506000-00012

Cited by 196 publications

(113 citation statements)

References 24 publications

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“…64 Both commercially available ECM matrices on the veterinary market are promoted as implantable products to accelerate wound healing in dogs and cats. Numerous studies have shown beneficial results in people in the treatment of wounds using PSIS [65][66][67] ; however, very few reports have thoroughly studied its application in clinical veterinary medicine. 20,29,68 Our purpose was to compare the effect of PSIS with a standard wound management protocol for large fullthickness wounds in dogs.…”

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confidence: 99%

Effect of Porcine Small Intestinal Submucosa on Acute Full‐Thickness Wounds in Dogs

et al. 2008

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Objective-To evaluate the effects of porcine small intestinal submucosa (PSIS) on the healing of full-thickness wounds in dogs, specifically the appearance of granulation tissue, percent epithelialization and contraction, histologic variables of inflammation and repair, and aerobic culture results. Study Design-Prospective, controlled, experimental study. Animals-Purpose-bred, female dogs (n ¼ 10). Methods-Wounds were created bilaterally on the trunk; 1 side as a control and 1 treated with PSIS. First appearance of granulation tissue was recorded. Total wound area, open wound area, and epithelialized area were measured at 21 time points-wound contraction and percent epithelialization were calculated. Aerobic cultures were taken at 4 time points and wound biopsies at 8. Histologic features were graded into an Acute Inflammation Score and Repair Score. Results-There was no difference in first appearance of granulation tissue between PSIS-treated and control wounds. Wound contraction was significantly faster in control wounds as was percent epithelialization after day 21. Histologic Acute Inflammation Scores were significantly higher in PSIS-treated wounds compared with control wounds on days 2 and 6. There were no differences in Histologic Repair Scores between PSIS-treated and control wounds or in aerobic culture results. Conclusion-Wounds treated with PSIS contract more slowly, epithelialize less, and have more pronounced acute inflammation after implantation than control wounds. Clinical Relevance-Acute, full-thickness wounds in dogs do not benefit from treatment with PSIS. r

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confidence: 99%

Effect of Porcine Small Intestinal Submucosa on Acute Full‐Thickness Wounds in Dogs

et al. 2008

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“…Data for the percentage of ulcers healed over a period of 12 weeks were obtained from pivotal randomized clinical trials found in the literature. [4][5][6][7][8][9] When the cost for 12 weeks of treatment is divided by the percentage of patients healed in 12 weeks, this gives a cost per 1% patients healed. Using Apligraf as an example in the context of a venous leg ulcer and four applications over 12 weeks, cost for duration of care is $6,816 as determined in first-level calculations.…”

Section: Resultsmentioning

confidence: 99%

Collect Data, Tell Stories: Utilizing Available Data to Improve Wound Product Selection, Reduce Costs, and Improve Outcomes

Mostow

Montemayor

Pittinger

et al. 2014

Advances in Wound Care

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Objective: To develop a tool to assist in the evaluation of treatment options based on clinically relevant parameters, thus enabling clinicians to heal patients more efficiently. Approach: Outlined here is the prototypic model of a comprehensive analysis tool to compare products by category, accounting for product characteristics, effectiveness data from literature, costs, and patient needs or clinician preferences.Results: The tool is demonstrated with a venous leg ulcer example, and ideas for expanding the tool in the future are provided. Innovation: Although this is a simple model, the authors believe that it provides a valid and useful platform for comparing similar products of a given type using available information and reflecting real-world use to give a practical approach to clinical decision-making. Conclusion: Future funding for comprehensive, comparative effectiveness studies should provide clarity on which products to choose for specific applications. Meanwhile, tools like this can provide guidance, and can be modified to accommodate varying circumstances.

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“…When IZN 6D4 is compared to results from the Apligraf study, it can be demonstrated that the response to IZN 6D4 is more rapid, and the response rate is greater even though a formal non-weight bearing regimen was not instituted in the IZN 6D4 study. IZN 6D4 also performs well when compared to other biological-based wound coverings including Dermagraft, OASIS wound matrix, and Regranex gel [24,25]. Extrapolating from the individual subject data, an additional 4 patients were on a trajectory for completing healing by 4-6 weeks.…”

Section: Discussionmentioning

confidence: 99%

A Pilot Study to Evaluate the Efficacy of IZN 6D4 for the Treatment of Diabetic Foot Ulcers

Oberbaum¹,

Rosenblum²

2017

J Diabetic Complications Med

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Diabetic foot ulcers (DFU), which can affect up to 15% of individuals with diabetes, remain a major unmet medical need. Left untreated, DFU seriously impact on quality of life and level of function. Conventional treatment is costly and often ineffective. In severe cases, patients with DFU may undergo painful amputations. IZN 6D4 is an impregnated hydrogel containing active pharmaceutical ingredients that have both wound-healing promoting and anti-inflammatory activities This is an observational human clinical trial study involving 15 patients treated with IZN 6D4. Subjects in the study had DFU which were categorized as being at stage 1A or greater using the University of Texas Health Science Center, San Antonio scale (UTHSC) grading system. Treatment lasted 21 days, and during the course of the study, patches were applied every 3-4 days. Response to therapy was measured by extent and depth of the lesion (wound grid and digital photography), qualitative assessment of wound healing (tissue granulation), and the rate of wound closure over the trial period. Results of the study showed that 40% of subjects had 75% closure of the wound and 27% had complete wound closure. Nearly all patients had evidence of active wound healing (e.g., presence of granulation tissue), and percent mean wound reduction for the entire study group was 67.7 ± 26.4%. Photo documentation of wound healing showed impressive differences between pre-and posttreatment appearances of diabetic ulcers in many of the patients studied. Based on the promising data from preclinical studies and the observational clinical trial provide strong justification for initiating a large-scale, longer duration clinical trial evaluating the efficacy of IZN 6D4 hydrogel in the treatment of patients with DFU.

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Randomized Clinical Trial Comparing OASIS Wound Matrix to Regranex Gel for Diabetic Ulcers

Abstract: Although the sample size was not large enough to demonstrate that the incidence of healing in the OASIS group was statistically superior (P = .055), the study results showed that treatment with OASIS is as effective as Regranex in healing full-thickness diabetic foot ulcers by 12 weeks.

Cited by 196 publications

References 24 publications

Effect of Porcine Small Intestinal Submucosa on Acute Full‐Thickness Wounds in Dogs

Effect of Porcine Small Intestinal Submucosa on Acute Full‐Thickness Wounds in Dogs

Collect Data, Tell Stories: Utilizing Available Data to Improve Wound Product Selection, Reduce Costs, and Improve Outcomes

A Pilot Study to Evaluate the Efficacy of IZN 6D4 for the Treatment of Diabetic Foot Ulcers

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