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Randomized Controlled Trial
. 2016 Aug 22;9(1):34.
doi: 10.1186/s13047-016-0163-4. eCollection 2016.

The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational

Kamel Mohammedi  1 , Louis Potier  2 , Maud François  3 , Dured Dardari  4 , Marilyne Feron  5 , Estelle Nobecourt-Dupuy  6 , Manuel Dolz  7 , Roxane Ducloux  8 , Abdelkader Chibani  9 , Dominique-François Eveno  10 , Teresa Crea Avila  11 , Ariane Sultan  12 , Laurence Baillet-Blanco  13 , Vincent Rigalleau  14 , Gilberto Velho  15 , Florence Tubach  16 , Ronan Roussel  2 , Jean-Claude Dupré  5 , Dominique Malgrange  3 , Michel Marre  2
Affiliations
Randomized Controlled Trial

The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational

Kamel Mohammedi et al. J Foot Ankle Res. .

Abstract

Background: Off-loading is essential for diabetic foot management, but remains understudied. The evaluation of Off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) trial aims to evaluate the efficacy of a new removable device "Orthèse Diabète" in the healing of diabetic foot.

Methods/design: ORTHODIAB is a French multi-centre randomized, open label trial, with a blinded end points evaluation by an adjudication committee according to the Prospective Randomized Open Blinded End-point. Main endpoints are adjudicated based on the analysis of diabetic foot photographs. Orthèse Diabète is a new removable off-loading orthosis (PROTEOR, France) allowing innovative functions including real-time evaluation of off-loading and estimation of patients' adherence. Diabetic patients with neuropathic plantar ulcer or amputation wounds (toes or transmetatarsal) are assigned to one of 2 parallel-groups: Orthèse Diabète or control group (any removable device) according to a central computer-based randomization. Study visits are scheduled for 6 months (days D7 and D14, and months M1, M2, M3, and M6). The primary endpoint is the proportion of patients whose principal ulcer is healed at M3. Secondary endpoints are: the proportion of patients whose principal ulcer is healed at M1, M2 and M6; the proportion of patients whose initial ulcers are all healed at M1, M2, M3, and M6; principal ulcer area reduction; time-related ulcer-free survival; development of new ulcers; new lower-extremity amputation; infectious complications; off-loading adherence; and patient satisfaction. The study protocol was approved by the French National Agency for Medicines and Health Products Safety, and by the ethics committee of Saint-Louis Hospital (Paris). Comprehensive study information including a Patient Information Sheet has been provided to each patient who must give written informed consent before enrolment. Monitoring, data management, and statistical analyses are providing by UMANIS Life Science (Paris), independently to the sponsor. Since 27/10/2013, 13 centres have agreed to participate in this study, 117 participants were included, and 70 have achieved the study schedules. The study completion is expected for the end of 2016, and the main results will be published in 2017.

Conclusion: ORTHODIAB trial evaluates an innovating removable off-loading device, seeking to improve diabetic foot healing (ClinicalTrials.gov identifier: NCT01956162).

Keywords: Device; Diabetic foot; Healing; Off-loading; Wound.

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Figures

Fig. 1
Fig. 1
Schematic illustration of “Orthèse Diabète” and its different components
Fig. 2
Fig. 2
Schedule of the study visits
See this image and copyright information in PMC

References

    1. Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005;366(9498):1719–1724. doi: 10.1016/S0140-6736(05)67698-2. - DOI - PubMed
    1. Muller IS, de Grauw WJ, van Gerwen WH, Bartelink ML, van Den Hoogen HJ, Rutten GE. Foot ulceration and lower limb amputation in type 2 diabetic patients in dutch primary health care. Diabetes Care. 2002;25(3):570–574. doi: 10.2337/diacare.25.3.570. - DOI - PubMed
    1. Iversen MM, Tell GS, Riise T, Hanestad BR, Ostbye T, Graue M, et al. History of foot ulcer increases mortality among individuals with diabetes: ten-year follow-up of the Nord-Trondelag Health Study. Norway Diabetes Care. 2009;32(12):2193–2199. doi: 10.2337/dc09-0651. - DOI - PMC - PubMed
    1. Moxey PW, Hofman D, Hinchliffe RJ, Jones K, Thompson MM, Holt PJ. Epidemiological study of lower limb amputation in England between 2003 and 2008. Br J Surg. 2010;97(9):1348–1353. doi: 10.1002/bjs.7092. - DOI - PubMed
    1. Taylor SM, Johnson BL, Samies NL, Rawlinson RD, Williamson LE, Davis SA, et al. Contemporary management of diabetic neuropathic foot ulceration: a study of 917 consecutively treated limbs. J Am Coll Surg. 2011;212(4):532–545. doi: 10.1016/j.jamcollsurg.2010.12.027. - DOI - PubMed

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