Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients

NCT01956162 | Completed DMC

• 1 other identifier: PROT-ORTHO-0913
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable devices in terms of healing of ulcers. \- Primary objective: Evaluate the efficiency of "Orthèse Diabète" compared to "conventional" removable devices, in terms of the proportion of diabetic patients whose principal ulcer will heal completely at 3 months.

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficiency of "Orthèse Diabète" compared to "conventional" removable devices, in terms of the proportion of diabetic patients whose principal ulcer will heal completely.

  Evaluated by taking photographs, measuring the ulcer area (using Digital Photo Planimetry DPP and the software Tracer.exe). Full healing defined by the adjudication committee based on the analysis of the photographs.

  At 3 months

Secondary Outcomes (9)

• Proportion of patients whose principal plantar ulcer will be fully healed

  At 1, 2 and 6 months

• Proportion of patients whose all initial plantar ulcers will be fully healed.

  At 1, 2, 3 and 6 months

• Percentage decrease of the ulcer area

  At 1, 2, 3 and 6 months

• Time to healing of the principal ulcer

  From the patient's off-loading device delivery visit to the date of healing validated by the adjudication committee

• Appearance of new ulcers on the affected foot and/or contralateral

  6 months

Study Arms (2)

Group "Orthèse Diabète"

EXPERIMENTAL

Using "Orthèse Diabète", a new customized removable device with rocker sole for plantar off-loading

Device: Orthèse Diabète

Control Group

ACTIVE COMPARATOR

Using "Conventional devices", removable off-loading systems among the devices available in France

Device: "Conventional" Device

Interventions

Orthèse Diabète DEVICE

The device ensures the discharge of the wound by the excavation of the orthopedic insole facing the wound and the load distribution in the healthy areas.

Group "Orthèse Diabète"

"Conventional" Device DEVICE

Standard (e.g.: CHUT, BAROUK, Tera-Diab, Sanital, Teraheel, Aircast boots, Walker Stabil D, etc.), or customized (orthopedic insole, Ransart boot, D.T.A.C.P., etc.) removable off-loading systems

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or type 2 diabetic patients diagnosed according to the ADA experts consensus \[ADA 1997\]
• Over 18 years of age
• With a sensory neuropathy (abnormal 10 g monofilament test, i.e. not perceived at least 2 times in 1 of the 3 areas explored : pulp of the great toe, 1st and 5th metatarsal heads)
• Without a severe arteriopathy defined by : ABI \< 0,7 and/or TcPO2 \< 30 mm Hg and/or big toe pressure \< 30 mm Hg
• with one or more plantar ulcerations with an area \> 0,25 cm² or an amputation (toes or transmetatarsal) open or sutured
• not requiring a contralateral off-loading device
• Informed about the study and having given their informed and written consent to participate
• registered with a social security scheme or with the CMU (beneficiary or entitled recipient)
• having undergone a medical exam
• not included in another protocol throughout the study

You may not qualify if:

• Severe skin or osteoarticular infection requiring a parenteral antibiotic therapy or surgery
• Large ulcer of the ipsilateral leg \> 20 cm2 of area
• Contralateral above heel amputation
• Intercurrent disease prohibiting participation in the protocol
• Weight over 130 Kg
• Person under tutorship or under curatorship
• Loss of functional and/or neuropsychological autonomy
• Pregnant or likely to be pregnant woman

Sponsors & Collaborators

• Proteor Group: lead
• Société Francophone du Diabète: collaborator

Study Sites (1)

Bichat Hospital

Paris, 75877, France

Location

Related Publications (14)

• Malgrange D. [Physiopathology of the diabetic foot]. Rev Med Interne. 2008 Sep;29 Suppl 2:S231-7. doi: 10.1016/S0248-8663(08)73950-X. French.

  PMID: 18822248 BACKGROUND

• Cavanagh PR, Lipsky BA, Bradbury AW, Botek G. Treatment for diabetic foot ulcers. Lancet. 2005 Nov 12;366(9498):1725-35. doi: 10.1016/S0140-6736(05)67699-4.

  PMID: 16291067 BACKGROUND

• Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber GE, Wagner EH. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999 Mar;22(3):382-7. doi: 10.2337/diacare.22.3.382.

  PMID: 10097914 BACKGROUND

• 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 Mar;25(3):570-4. doi: 10.2337/diacare.25.3.570.

  PMID: 11874949 BACKGROUND

• Detournay B, Cros S, Charbonnel B, Grimaldi A, Liard F, Cogneau J, Fagnani F, Eschwege E. Managing type 2 diabetes in France: the ECODIA survey. Diabetes Metab. 2000 Nov;26(5):363-9.

  PMID: 11119015 BACKGROUND

• Detournay B, Raccah D, Cadilhac M, Eschwege E. Epidemiology and costs of diabetes treated with insulin in France. Diabetes Metab. 2005 Jun;31(3 Pt 2):3-18.

  PMID: 16142041 BACKGROUND

• Malgrange D, Richard JL, Leymarie F; French Working Group On The Diabetic Foot. Screening diabetic patients at risk for foot ulceration. A multi-centre hospital-based study in France. Diabetes Metab. 2003 Jun;29(3):261-8. doi: 10.1016/s1262-3636(07)70035-6.

  PMID: 12909814 BACKGROUND

• Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993 Jun;233(6):485-91. doi: 10.1111/j.1365-2796.1993.tb01003.x.

  PMID: 8501419 BACKGROUND

• Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. doi: 10.1016/S0140-6736(05)67698-2.

  PMID: 16291066 BACKGROUND

• 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 Sep;97(9):1348-53. doi: 10.1002/bjs.7092.

  PMID: 20632310 BACKGROUND

• Resnick HE, Carter EA, Sosenko JM, Henly SJ, Fabsitz RR, Ness FK, Welty TK, Lee ET, Howard BV; Strong Heart Study. Incidence of lower-extremity amputation in American Indians: the Strong Heart Study. Diabetes Care. 2004 Aug;27(8):1885-91. doi: 10.2337/diacare.27.8.1885.

  PMID: 15277412 BACKGROUND

• Fosse S, Hartemann-Heurtier A, Jacqueminet S, Ha Van G, Grimaldi A, Fagot-Campagna A. Incidence and characteristics of lower limb amputations in people with diabetes. Diabet Med. 2009 Apr;26(4):391-6. doi: 10.1111/j.1464-5491.2009.02698.x.

  PMID: 19388969 BACKGROUND

• Potier L, Francois M, Dardari D, Feron M, Belhatem N, Nobecourt-Dupuy E, Dolz M, Bordier L, Ducloux R, Chibani A, Eveno DF, Crea Avila T, Sultan A, Baillet-Blanco L, Rigalleau V, Gand E, Saulnier PJ, Velho G, Roussel R, Pellenc Q, Dupre JC, Malgrange D, Marre M, Mohammedi K; ORTHODIAB study group. Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial. BMJ Open Diabetes Res Care. 2020 May;8(1):e000954. doi: 10.1136/bmjdrc-2019-000954.

  PMID: 32393479 DERIVED

• Mohammedi K, Potier L, Francois M, Dardari D, Feron M, Nobecourt-Dupuy E, Dolz M, Ducloux R, Chibani A, Eveno DF, Crea Avila T, Sultan A, Baillet-Blanco L, Rigalleau V, Velho G, Tubach F, Roussel R, Dupre JC, Malgrange D, Marre M. The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational. J Foot Ankle Res. 2016 Aug 22;9(1):34. doi: 10.1186/s13047-016-0163-4. eCollection 2016.

  PMID: 27555884 DERIVED

Related Links

• Francophone Diabetes Society Website

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Kamel Mohammedi, Diabetology

  Bichat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

FR (1)