NCT01586481

Brief Summary

It's a pilot prospective opened multicentric randomised study. We measure the efficiency and the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with BAROUK shoe

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_3 diabetes-mellitus

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 14, 2013

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

April 25, 2012

Last Update Submit

November 13, 2013

Conditions

Diabetes MellitusDiabetic Neuropathic Foot Ulcer

Keywords

Diabetic foot ulcerOff loadingComplianceHealing durationAmputation rate

Outcome Measures

Primary Outcomes (1)

  • Healing duration of the diabetic foot ulcer

    6 months

Secondary Outcomes (3)

  • Rate of reulceration

    6 months

  • Rate of amputation

    6 months

  • Compliance of patients to footwear

    6 months

Study Arms (2)

barouk

ACTIVE COMPARATOR
Device: BAROUK

sanidiab

EXPERIMENTAL
Device: SANIDIAB

Interventions

SANIDIABDEVICE

off-loading shoe

sanidiab
BAROUKDEVICE

old shoe

barouk

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More of 18 years old man or woman
  • Type 1 or 2 Diabetes mellitus
  • A new plantar ulcer of the fore foot or the toes
  • GRADE 1A or 2 A of the University of Texas Classification
  • Neuropathy assessed by absence of sensation in 10g monofilament test

You may not qualify if:

  • Severe angiopathy (Grade 3 of the PEDIS classification)
  • Osteomyelitis or cellulitis of the foot
  • Transmetatarsal amputation
  • Other study in course
  • Immunosuppressive drugs, antibiotic therapy,
  • Hepatic insufficiency
  • No possibility to follow the patients every 14 days
  • No state health insurance
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic FootPatient Compliance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic NeuropathiesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Georges HA VAN, MD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 26, 2012

Study Start

June 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 14, 2013

Record last verified: 2013-05

Locations

FR(1)