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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01956162
Other study ID # PROT-ORTHO-0913
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 allClick 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
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