New Consensus Guidelines and Practical Recommendations Published on the Optimal Use of Off-Loading in Diabetic Foot Ulcer Treatment

Evidence is Clear that Adequate Off-Loading Increases the Likelihood of DFU Healing

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Dec 17, 2014, 09:03 ET

PRINCETON, N.J., Dec. 17, 2014 /PRNewswire-USNewswire/ -- Relieving pressure on the foot through the use of "off-loading" improves healing outcomes and reduces complications in patients with diabetic foot ulcers (DFUs), according to consensus guidelines published today in the Journal of the American Podiatric Medical Association. "The Management of Diabetic Foot Ulcers Through Optimal Off-Loading – Building Consensus Guidelines and Practical Recommendations to Improve Outcomes," was authored by a multidisciplinary panel of nine experts who were supported by Derma Sciences, Inc (Nasdaq: DSCI). The document was developed to provide evidence-based consensus on the optimal use of off-loading as treatment for DFUs, a debilitating and costly condition that can lead to amputation of the foot and other lower extremities.

Fifteen percent of patients who have diabetes are at risk for developing a DFU¹ and 85 percent of lower extremity amputations in diabetic patients are preceded by a foot ulcer.² The projected lifetime health care cost for patients with DFUs who undergo amputation is approximately $509,000.³

"Publishing this paper is intended to bridge the gap between evidence supporting the effectiveness of off-loading for diabetic foot ulcers and its use in clinical practice, and to guide the wound care decision-making process," said Robert J. Snyder, DPM, MSc, Professor and Director of Clinical Research at Barry University School of Podiatric Medicine and lead author of the consensus guidelines. "It is our hope that this manuscript will foster meaningful off-loading of DFUs by the specialist and generalist alike."

According to Dr. Caroline E. Fife, Chief Medical Officer of Intellicure and Executive Director of the U.S. Wound Registry, even with optimal management of all other factors, DFU healing is unlikely in the absence of adequate pressure relief, making off-loading an essential part of managing the condition.^4,5,6 However, off-loading was documented in only 2.2 percent of 221,192 DFU visits from January 2, 2007 to January 6, 2013.⁷

The paper's authors found total contact casting (TCC) demonstrates success in healing outcomes for patients with DFUs because of its mode of action and non-removable design.⁸Derma Sciences' TCC-EZ® Total Contact Cast System is an easy-to-use, one-piece, roll-on design that simplifies casting while reducing the potential to cause additional tissue damage. According to Dr. Fife, clinics using TCC-EZ® treat four times as many DFU patients using TCC compared with clinics using traditional TCC systems.⁷

A literature review of approximately 90 studies conducted by the expert panel resulted in the following eight evidence-based consensus guidelines and core recommendations:

Consensus Statement #1: The VIPs (vascular management, infection management and prevention, and pressure relief) are essential to DFU healing.
Consensus Statement #2: Adequate off-loading increases the likelihood of DFU healing.
Consensus Statement #3: For guidance on off-loading the Charcot foot, the panel endorses the Charcot foot in diabetes consensus report published in 2011.
Consensus Statement #4: TCC is the preferred method for off-loading plantar DFUs, as it has most consistently demonstrated the best healing outcomes and is a cost-effective treatment.
Consensus Statement #5: There currently exists a "gap" between the evidence supporting the efficacy of DFU off-loading and what is performed in clinical practice.
Consensus Statement #6: The likelihood of DFU healing is increased with off-loading adherence.
Consensus Statement #7: Advanced therapeutics are unlikely to succeed in improving wound-healing outcomes unless effective off-loading is obtained.
Consensus Statement #8: The panel supports the development of a per-visit off-loading quality measure to address the gap between evidence of off-loading and its current use in clinical practice.

To read "The Management of Diabetic Foot Ulcers through Optimal Off-Loading – Building Consensus Guidelines and Practical Recommendations to Improve Outcomes," visit http://www.japmaonline.org/doi/abs/10.7547/8750-7315-104.6.555. Following is the complete list of experts who participated in the panel to develop these guidelines:

Robert J. Snyder, DPM, MSc
Professor and Director of Clinical Research at Barry University SPM and President of the Association for the Advancement of Wound Care
Lead author of "The Management of Diabetic Foot Ulcers Through Optimal Off-Loading – Building Consensus Guidelines and Practical Recommendations to Improve Outcomes"
Robert G. Frykberg, DPM, MPH
Chief of the Podiatry Section and Podiatric Residency Director at the Carl T. Hayden Veterans Affairs Medical Center and Adjunct Professor, Midwestern University Program in Podiatric Medicine
Lee C. Rogers, DPM
Co-director of the Amputation Prevention Center at Valley Presbyterian Hospital and the Medical Director of Paradigm Medical Management
Andrew J. Applewhite, MD
Medical Director at the Comprehensive Wound Center of Baylor University Medical Center
Desmond Bell, DPM
Co-founder and Executive Director of the "Save A Leg, Save A Life" Foundation
Gregory Bohn, MD
Director of the Trinity Center for Wound Care and Hyperbaric Medicine at Trinity Bettendorf and Moline Clinics at Trinity Regional Medical Center
Caroline E. Fife, MD
Chief Medical Officer of "Intellicure," and Executive Director of the U.S. Wound Registry
Jeffrey Jensen, DPM
Director of Research at the Barry University School of Podiatric Medicine and developer of the first commercially viable standardized Total Contact Casting kit
James Wilcox, RN
Director of Research & Quality for Medical Affairs for Healogics, Inc.

About Diabetic Foot Ulcers
If left untreated, diabetic foot wounds can become serious, placing a patient at risk for amputation and other life-threatening conditions. Early and effective management of the wound is the safest route to preventing complications.

Eighty-five percent of lower extremity amputations in diabetic patients are preceded by a foot ulcer.² Additionally, the five-year mortality rate in diabetic patients who underwent lower extremity amputation is approximately 60 percent.⁹

About Derma Sciences, Inc.
Derma Sciences is a tissue regeneration company focused on advanced wound and burn care. It offers a line of products with patented technologies to help better manage chronic and hard-to-heal wounds, many of which result from diabetes and poor vascular functioning. The company recently entered the $500 million market for skin substitute products with its licensing of AMNIOEXCEL® and AMNIOMATRIX® in the first quarter of 2014. AMNIOEXCEL® was launched to customers in March 2014 and AMNIOMATRIX® was launched in the second quarter. Its MEDIHONEY® product is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown in clinical studies to be effective in a variety of indications. TCC-EZ® is its gold-standard total contact casting system for diabetic foot ulcers. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, and BIOGUARD® for barrier protection against microbes and other contaminants. Its pharmaceutical wound care products include DSC127, which is currently in Phase 3 clinical trials for the healing of diabetic foot ulcers. The drug candidate is also part of a BARDA grant program for the healing/prevention of tissue damage due to ionizing radiation exposure. The patented API peptide used in DSC127 is also in preclinical testing for scar prevention/reduction. The company also offers a full product line of traditional dressings.

For more information please visit www.dermasciences.com.

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CONTACT:
Derma Sciences, Inc.
Barry Wolfenson, (609) 514-4744
Group President, Advanced Wound Care and Pharmaceutical Development
[email protected]
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References:

National Diabetes Data Group: Diabetes in America, Vol. 2. Bethesda, MD, National Institutes of Health 1995 (NIH publ. no. 95-1468).
Incidence of diabetic foot ulcer and lower extremity amputation among Medicare beneficiaries, 2006 to 2008, www.ahrq.gov.
MacKenzie EJ1, et al. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. J Bone Joint Surg Am. 2007 Aug;89(8):1685-92.
Snyder RJ, Kirsner RS, Warriner RA 3rd, Lavery LA, Hanft JR, Sheehan P. Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage 2010;56(Suppl 4):S1-24.
Frykberg RG, Rogers LC. Emerging evidence on advanced wound care for diabetic foot ulcerations. Proceedings from the Superbones West Conference; October 21-24, 2010; Las Vegas, Nevada. Supplement to Podiatry Today, 2010.
Boulton AJ. Pressure and the diabetic foot: clinical science and offloading techniques. Am J Surg 2004;187(5A):17S-24S.
Fife CE, Carter MJ, Walker D, et al. Diabetic foot ulcer off-loading: the gap between evidence and practice. Data from the US Wound Registry. Adv Skin Wound Care. 2014; 27(7):310-16.
Armstrong DG, Nguyen HC, Lavery LA, et al: Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care 24: 1019, 2001.
Margolis DJ, Hofstad O, Feldman, H: Association Between Renal Failure and Foot Ulcer or Lower-Extremity Amputation in Patients With Diabetes, Diabetes Care. 2008 July; 31(7): 1331–1336.