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

Primary Purpose

Foot Ulcer, Diabetic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Orthèse Diabète
"Conventional" Device
Sponsored by
Proteor Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bichat Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group "Orthèse Diabète"

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
Time to healing of the principal ulcer
Appearance of new ulcers on the affected foot and/or contralateral
The following elements will be specified: cause, side, location, severity, treatment used
Requirement for amputation
The following elements will be specified: date, side and level.
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.
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
Patients satisfaction with the prescribed device
Evaluated with the "QUEST ESAT" questionnaire

Full Information

First Posted
September 26, 2013
Last Updated
May 31, 2017
Sponsor
Proteor Group
Collaborators
Société Francophone du Diabète
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1. Study Identification

Unique Protocol Identification Number
NCT01956162
Brief Title
Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proteor Group
Collaborators
Société Francophone du Diabète

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Secondary objectives Proportion of patients whose principal ulcer will heal completely at 1, 2 and 6 months Proportion of patients in whom all initial plantar ulcers will heal completely at 1, 2, 3 and 6 months Percentage of area decrease of the plantar ulcers at 1, 2, 3 and 6 months Time to healing of the principal ulcer Appearance of new ulcers Requirement for amputation Incidence of the infectious complications Adherence of wearing Patient's satisfaction with the prescribed device Population 13 centers/116 patients monitored for a period of 6 months maximum Experimental Group: "Orthèse Diabète" a plantar off-loading custom-made removable device Control group: "Conventional" removable off-loading systems among the devices available in France.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group "Orthèse Diabète"
Arm Type
Experimental
Arm Description
Using "Orthèse Diabète", a new customized removable device with rocker sole for plantar off-loading
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Using "Conventional devices", removable off-loading systems among the devices available in France
Intervention Type
Device
Intervention Name(s)
Orthèse Diabète
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
"Conventional" Device
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Proportion of patients whose principal plantar ulcer will be fully healed
Description
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.
Time Frame
At 1, 2 and 6 months
Title
Proportion of patients whose all initial plantar ulcers will be fully healed.
Description
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.
Time Frame
At 1, 2, 3 and 6 months
Title
Percentage decrease of the ulcer area
Description
The area is evaluated by the last measurement undertaken during the trial or prior to a serious event (death, amputation, orthopedic or vascular surgery).
Time Frame
At 1, 2, 3 and 6 months
Title
Time to healing of the principal ulcer
Time Frame
From the patient's off-loading device delivery visit to the date of healing validated by the adjudication committee
Title
Appearance of new ulcers on the affected foot and/or contralateral
Description
The following elements will be specified: cause, side, location, severity, treatment used
Time Frame
6 months
Title
Requirement for amputation
Description
The following elements will be specified: date, side and level.
Time Frame
6 months
Title
Incidence of infectious complications
Description
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.
Time Frame
6 months
Title
Observance of the equipment
Description
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
Time Frame
6 months
Title
Patients satisfaction with the prescribed device
Description
Evaluated with the "QUEST ESAT" questionnaire
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamel Mohammedi, Diabetology
Organizational Affiliation
Bichat Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bichat Hospital
City
Paris
ZIP/Postal Code
75877
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18822248
Citation
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Citation
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.
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Citation
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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.
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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.
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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.
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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.
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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.
Results Reference
derived
Links:
URL
http://www.sfdiabete.org/
Description
Francophone Diabetes Society Website

Learn more about this trial

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

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