NCT02818322

Brief Summary

The role of telemedical monitoring in diabetic foot care is still uncertain. The aim is to compare telemedical + standard and standard alone outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. The primary outcome of the overall study is the time of ulcer healing. The number of amputation, hospital admissions and surgical procedure will be also reported. Investigators hope to include 150 patients in this study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

June 23, 2016

Last Update Submit

June 27, 2016

Conditions

Diabetic Foot - Telemedical Monitoring

Outcome Measures

Primary Outcomes (1)

  • time of ulcer healing

    6 month after inclusion

Study Arms (2)

telemedical monitoring ( T)

EXPERIMENTAL

Home care by a nurse trained in the management of diabetic foot lesions with transmission diabetologist doctor a photograph and a full description of the diabetic foot lesion every week

Device: telemedical monitoring ( T)Device: classic monitoring

classic monitoring

ACTIVE COMPARATOR

Home care by a nurse trained in the management of diabetic foot lesions without transmission diabetologist doctor a photograph and a full description of the diabetic foot lesion

Device: classic monitoring

Interventions

telemedical monitoring ( T)DEVICE
telemedical monitoring ( T)
classic monitoringDEVICE
classic monitoringtelemedical monitoring ( T)

Eligibility Criteria

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

You may qualify if:

  • Patients with care of this lesion of diabetic foot externally.
  • Patients who agreed to participate in or accepting ORNICARE network ( network for the transmission of information between health care professionals) (Appendix 3) .
  • Patients aged over 18 years .
  • Patients who agreed to participate in the study .
  • The patients insured by a social security scheme .

You may not qualify if:

  • Patients requiring hospital care of the lesion of diabetic foot (infection requiring surgical intervention , ischemia requiring revascularization , ...).
  • Patients are protected by law .
  • Minor patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

RECRUITING

Central Study Contacts

Maud FRANCOIS

CONTACT

mfrancois@chu-reims.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 29, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

FR(1)