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

Foot Ulcer, Diabetic Clinical Trial

— ORTHODIAB  

Official title:

Evaluation of a New Customized Removable Device With Rocker Sole for Plantar Off-Loading "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956162
• Other study ID #: PROT-ORTHO-0913
• Status: Completed
• Phase: N/A
• First received: September 26, 2013
• Last updated: May 31, 2017
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Proteor Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. Secondary objectives

1. Proportion of patients whose principal ulcer will heal completely at 1, 2 and 6 months

2. Proportion of patients in whom all initial plantar ulcers will heal completely at 1, 2, 3 and 6 months

3. Percentage of area decrease of the plantar ulcers at 1, 2, 3 and 6 months

4. Time to healing of the principal ulcer

5. Appearance of new ulcers

6. Requirement for amputation

7. Incidence of the infectious complications

8. Adherence of wearing

9. Patient's satisfaction with the prescribed device

2. Population

1. 13 centers/116 patients monitored for a period of 6 months maximum

2. Experimental Group: "Orthèse Diabète" a plantar off-loading custom-made removable device

3. Control group: "Conventional" removable off-loading systems among the devices available in France.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Device:
• Orthèse Diabète
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.
• "Conventional" 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

Locations

Country	Name	City	State
France	Bichat Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Proteor Group	Société Francophone du Diabète

Country where clinical trial is conducted

France, 

References & Publications (12)

Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993 Jun;233(6):485-91. — View Citation

Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. Review. — View Citation

Cavanagh PR, Lipsky BA, Bradbury AW, Botek G. Treatment for diabetic foot ulcers. Lancet. 2005 Nov 12;366(9498):1725-35. Review. — View Citation

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

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

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. — View Citation

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. — View Citation

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. Review. French. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients whose principal plantar ulcer will be fully healed	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 1, 2 and 6 months
Secondary	Proportion of patients whose all initial plantar ulcers will be fully healed.	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 1, 2, 3 and 6 months
Secondary	Percentage decrease of the ulcer area	The area is evaluated by the last measurement undertaken during the trial or prior to a serious event (death, amputation, orthopedic or vascular surgery).	At 1, 2, 3 and 6 months
Secondary	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
Secondary	Appearance of new ulcers on the affected foot and/or contralateral	The following elements will be specified: cause, side, location, severity, treatment used	6 months
Secondary	Requirement for amputation	The following elements will be specified: date, side and level.	6 months
Secondary	Incidence of infectious complications	This covers cutaneous infections (abscess and lymphangitis, erysipelas, hypodermitis, necrotizing fasciitis, gas gangrene), bone infections (osteitis, arthritis, osteoarthritis) or systemic infections requiring antibiotic therapy (oral or parenteral) or surgery.	6 months
Secondary	Observance of the equipment	Daily wear will be evaluated in the 2 groups through a semi-quantitative questionnaire provided to the patient at every visit. This evaluation will be supplemented with readings of the thermal sensor in the "Orthèse Diabète " group	6 months
Secondary	Patients satisfaction with the prescribed device	Evaluated with the "QUEST ESAT" questionnaire	At 3 months

External Links

•   Francophone Diabetes Society Website