References

Clinical Practice Recommendations: foot care in patients with diabetes mellitus. Diabetes Care. 1996; 19

Singh N., Armstrong D.G., Lipsky B.A. Preventing foot ulcers in patients with diabetes. JAMA. 2005; 293:217-228

Gregg E.W., Gu Q., Williams D. Prevalence of lower extremity diseases associated with normal glucose levels, impaired fasting glucose, and diabetes among U.S. adults aged 40 or older. Diabetes Res Clin Pract. 2007; 77:(3)485-488

Jeffcoate W.J., Harding K.G. Diabetic foot ulcers. Lancet. 2003; 361:(9368)1545-1551

Stockl K., Vanderplas A., Tafesse E., Chang E. Costs of lower-extremity ulcers among patients with diabetes. Diabetes Care. 2004; 27:2129-2134

Rice J.B., Desai U., Cummings A.K. Burden of diabetic foot ulcers for Medicare and private insurers. Diabetes Care. 2014; 37:(3)651-658

Hinchliffe R.J., Valk G.D., Apelqvist J. Specific guidelines on wound and wound-bed management. Diabetes Metab Res Rev. 2008; 24:(S1)S188-S189

Game F.L., Hinchliffe R.J., Apelqvist J. A systematic review of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev. 2012; 28:(S1)119-141

Ramsey S.D., Newton K., Blough D. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999; 22:382-387

American Diabetes Association Statistics about diabetes. 2014. http://www.diabetes.org/diabetes-basics/statistics/ (accessed 19 September 2016)

Marston W.A., Hanft J., Norwood P. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003; 26:1701-1705

Snyder R.J., Kirsner R.S., Warriner R.A. Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage. 2010; 56:S1-S24

National Institute for Health and Care Excellence. Diabetic foot problems: prevention and management. NICE guideline NG19. 2015. http://tinyurl.com/hnjuqrt (accessed 19 September 2016)

Santema T.B., Poyck P.P., Ubbink D.T. Skin grafting and tissue replacement for treating foot ulcers in people with diabetes. Cochrane Database Syst Rev. 2016; (2)

Hyperbaric oxygen therapy: a brief history and review of its benefits and indications for the older adult patient. 2014. http://tinyurl.com/jjgvkp9 (accessed 19 September 2016)

Hasan M.Y., Teo R., Nather A. Negative-pressure wound therapy for management of diabetic foot wounds: a review of the mechanism of action, clinical applications, and recent developments. Diabet Foot Ankle. 2015; 6 https://doi.org/10.3402/dfa.v6.27618

U.S. Bureau of Labor Statistics. Annual Consumer Price Index website. http://www.bls.gov/cpi/home.htm (accessed March 2016)

Editorial Group: Cochrane Wounds Group. Skin grafting and tissue replacement for treating foot ulcers in people with diabetes. 2016. http://www.cochrane.org/CD011255/WOUNDS_skin-grafting-and-tissue-replacement-treating-foot-ulcers-people-diabetes (accessed March 2016)

Diabetic foot ulcers
Leg ulcers

A comparative analysis of skin substitutes used in the management of diabetic foot ulcers

02 July 2017
Research
02 July 2017
Volume 1 · Issue 3

Abstract

Objective:

To compare the relative product cost and clinical outcomes of four skin substitutes used as adjunctive treatments for diabetic foot ulcers (DFUs).

Method:

Medicare claims data from 2011 to 2014 were used to identify beneficiaries with diabetes and foot ulcers. Patients treated with one of four types of skin substitute (Apligraf, Dermagraft, OASIS, and MatriStem) were identified. The skin substitutes were compared on episode length; amputation rate; skin substitute utilisation; and skin substitute costs.

Results:

There were 13,193 skin substitute treatment episodes: Apligraf (HML) was used in 4926 (37.3%), Dermagraft (HSL) in 5530 (41.9%), OASIS (SIS) in 2458 (18.6%) and MatriStem (UBM) in 279 (2.1%). The percentage of DFUs that healed at 90 days were: UBM 62%; SIS 63%; HML 58%; and HSL 58%. Over the entire time, UBM was non-inferior to SIS (p<0.001), and either was significantly better than HML or HSL (p<0.005 in all four tests). HML was marginally superior to HSL (p=0.025 unadjusted for multiple testing). Medicare reimbursements for skin substitutes per DFU episode for UBM ($1435 in skin substitutes per episode) and SIS ($1901) appeared to be equivalent to each other, although non-inferiority tests were not significant. Both were less than HML ($5364) or HSL ($14,424) (p<0.0005 in all four tests). HML was less costly than HSL (p<0.0005).

Conclusion:

Various types of skin substitutes appear to be able to confer important benefits to both patients with DFUs and payers. Analysis of the four skin-substitute types resulted in a demonstration that UBM and SIS were associated with both shorter DFU episode lengths and lower payer reimbursements than HML and HSL, while HML was less costly than HSL but equivalent in healing.

Among the nearly 30 million Americans with type 1 or type 2 diabetes mellitus (DM), the annual incidence of developing a diabetic foot ulcer (DFU) is estimated to be between 1–4%, with a lifetime risk of between 25–30%.1,2,3 The overall direct medical costs of the treatment of each DFU may exceed $45,000.4,5 In the US, the treatment of DFUs impose a substantial annual burden on public and private payers, ranging from $9–13 billion, which is in addition to the costs associated with treatments for the underlying diabetes.6

Healing and wound closure fail in 24–60% of DFUs.7,8 DFUs are reported to account for up to two-thirds of all non-traumatic surgical lower limb amputations in the US.3,9 In 2010, an estimated 73,000 lower limb amputations were performed in patients with DM, and ischaemic and infected DFUs were responsible for 25% of all hospital stays in patients with diabetes.10

Register now to continue reading

Thank you for visiting Wound Central and reading some of our peer-reviewed resources for wound care professionals. To read more, please register today. You’ll enjoy the following great benefits:

What's included

  • Access to clinical or professional articles

  • New content and clinical updates each month

Register
Or continue by

Signing in with your registered email address

cost-effectiveness analysis
diabetic foot ulcer
MatriStem
skin substitutes
wound healing