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Foot Ulcer, DiabeticORTHODIABNCT01956162

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

A study testing Orthèse Diabète and "Conventional" Device in people with Foot Ulcer, Diabetic, run by Proteor Group at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Foot Ulcer, Diabetic
What is being tested?
Orthèse Diabète and "Conventional" Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteFrance
Study dates
Oct 2013to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Bichat Hospital

    Paris, 75877

Other trials in France

About this study

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

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.
Read the detailed description
  1. Secondary objectives
  2. Proportion of patients whose principal ulcer will heal completely at 1, 2 and 6 months
  3. Proportion of patients in whom all initial plantar ulcers will heal completely at 1, 2, 3 and 6 months
  4. Percentage of area decrease of the plantar ulcers at 1, 2, 3 and 6 months
  5. Time to healing of the principal ulcer
  6. Appearance of new ulcers
  7. Requirement for amputation
  8. Incidence of the infectious complications
  9. Adherence of wearing
  10. Patient's satisfaction with the prescribed device
  11. Population
  12. 13 centers/116 patients monitored for a period of 6 months maximum
  13. Experimental Group: "Orthèse Diabète" a plantar off-loading custom-made removable device
  14. Control group: "Conventional" removable off-loading systems among the devices available in France.
Being tested
Orthèse Diabète, "Conventional" Device
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orthèse DiabèteDevice

    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" DeviceDevice

    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

Study groups in NCT01956162
Study groupRoleWhat they receive
Group "Orthèse Diabète"ExperimentalUsing "Orthèse Diabète", a new customized removable device with rocker sole for plantar off-loading
Receives: Device: Orthèse Diabète
Control GroupActive comparatorUsing "Conventional devices", removable off-loading systems among the devices available in France
Receives: Device: "Conventional" Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 3 months

Secondary outcomes (9)

  1. 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.

    Measured: At 1, 2 and 6 months

  2. 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.

    Measured: At 1, 2, 3 and 6 months

  3. 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).

    Measured: At 1, 2, 3 and 6 months

  4. Time to healing of the principal ulcer

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

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

    The following elements will be specified: cause, side, location, severity, treatment used

    Measured: 6 months

  6. Requirement for amputation

    The following elements will be specified: date, side and level.

    Measured: 6 months

  7. 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.

    Measured: 6 months

  8. 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

    Measured: 6 months

  9. Patients satisfaction with the prescribed device

    Evaluated with the "QUEST ESAT" questionnaire

    Measured: At 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionNov 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01956162
Sponsor's protocol ID
PROT-ORTHO-0913
Acronym
ORTHODIAB
Status last verified
May 2017
First submitted
26 Sep 2013
Last updated
1 Jun 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 18822248

  • 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.

    PubMed 16291067

  • 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.

    PubMed 10097914

  • 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.

    PubMed 11874949

  • 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.

    PubMed 11119015

  • 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.

    PubMed 16142041

  • 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.

    PubMed 12909814

  • 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.

    PubMed 8501419

  • 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.

    PubMed 16291066

  • 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.

    PubMed 20632310

  • 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.

    PubMed 15277412

  • 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.

    PubMed 19388969

  • 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.

    PubMed 32393479

  • 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.

    PubMed 27555884

Questions about this trial

What is this clinical trial studying?

A study testing Orthèse Diabète and "Conventional" Device in people with Foot Ulcer, Diabetic, run by Proteor Group at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: At 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01956162, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.

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