NCT01710774

Brief Summary

This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers and people with leg ulcers (without diabetes) in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in specialist health care (noninferiority trial) in relation to healing time.

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
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

April 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 21, 2023

Status Verified

June 1, 2021

Enrollment Period

10.2 years

First QC Date

October 17, 2012

Last Update Submit

April 19, 2023

Conditions

Diabetic FootFoot Ulcer

Keywords

Diabetic FootDiabetes MellitusFoot UlcerWound HealingDelivery of Health CareDepressionsequelaSick LeaveQuality of LifeAmputationLegg ulcerHospitalizationHealth Economics

Outcome Measures

Primary Outcomes (1)

  • healing time for leg ulcer and/or diabetes related foot ulcer

    Healing time for leg ulcer and/or diabetes related foot ulcer measured from the time the person is included in the study until the foot ulcer is healed or the study ends (after 12 months). The effect will be measured in terms of hazard ratios (HR) and sub-hazard ratio (SHR) with healing as the endpoint and non-inferiority will be defined as \<40% increased healing time in the TM-group, i.e. the lower 95% confidence limit should not be lower than 0.60.

    one year

Secondary Outcomes (8)

  • Total number of consultations per patient

    one year

  • sequela directly related to the foot ulcer

    one year

  • Diabetes-related stress

    one year

  • Symptoms of anxiety and depression

    one year

  • Nordic Patient Experiences Questionnaire

    one year

  • +3 more secondary outcomes

Study Arms (2)

Traditional follow-up

NO INTERVENTION

Traditional follow-up with standard consultations at the Section of Endocrinology. For some patients, this will include follow-up from nurses in the home care or general practice office related to wound care. However, this is not the standard procedure and will not take place in combination with telemedicine follow-up.

Telemedicine follow-up care

ACTIVE COMPARATOR

Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care

Procedure: Telemedicine follow-up care

Interventions

Telemedicine follow-up carePROCEDURE

Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care

Telemedicine follow-up care

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • people with type 1 or type 2 diabetes with a new foot ulcer presenting for the first time within a period of 6 months and people without diabetes presenting a venous leg ulcer
  • The participants must be able to read and speak Norwegian.
  • The participants must be 20 years or older.

You may not qualify if:

  • \- people treated for an diabetes foot ulcer on the ipsilateral foot during the past 6 months in specialist health care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stavanger HF

Stavanger, Rogaland, 4068, Norway

Location

Haukeland University Hospital

Bergen, Norway

Location

Stord Hospital, Helse Fonna HF

Leirvik, Norway

Location

Related Publications (6)

  • Blytt KM, Kolltveit BH, Graue M, Robberstad M, Ternowitz T, Carlsen S, Iversen MM. The implementation of telemedicine in wound care: a qualitative study of nurses' and patients' experiences. BMC Health Serv Res. 2024 Sep 29;24(1):1146. doi: 10.1186/s12913-024-11620-w.

    PMID: 39343892DERIVED

  • Iversen MM, Igland J, Smith-Strom H, Ostbye T, Tell GS, Skeie S, Cooper JG, Peyrot M, Graue M. Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo). BMC Endocr Disord. 2020 Oct 21;20(1):157. doi: 10.1186/s12902-020-00637-x.

    PMID: 33087074DERIVED

  • Smith-Strom H, Igland J, Ostbye T, Tell GS, Hausken MF, Graue M, Skeie S, Cooper JG, Iversen MM. The Effect of Telemedicine Follow-up Care on Diabetes-Related Foot Ulcers: A Cluster-Randomized Controlled Noninferiority Trial. Diabetes Care. 2018 Jan;41(1):96-103. doi: 10.2337/dc17-1025. Epub 2017 Nov 29.

    PMID: 29187423DERIVED

  • Smith-Strom H, Iversen MM, Graue M, Skeie S, Kirkevold M. An integrated wound-care pathway, supported by telemedicine, and competent wound management-Essential in follow-up care of adults with diabetic foot ulcers. Int J Med Inform. 2016 Oct;94:59-66. doi: 10.1016/j.ijmedinf.2016.06.020. Epub 2016 Jun 29.

    PMID: 27573312DERIVED

  • Iversen MM, Espehaug B, Hausken MF, Graue M, Ostbye T, Skeie S, Cooper JG, Tell GS, Gunther BE, Dale H, Smith-Strom H, Kolltveit BC, Kirkevold M, Rokne B. Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo). JMIR Res Protoc. 2016 Jul 18;5(3):e148. doi: 10.2196/resprot.5646.

    PMID: 27430301DERIVED

  • Kolltveit BC, Gjengedal E, Graue M, Iversen MM, Thorne S, Kirkevold M. Telemedicine in diabetes foot care delivery: health care professionals' experience. BMC Health Serv Res. 2016 Apr 18;16:134. doi: 10.1186/s12913-016-1377-7.

    PMID: 27091459DERIVED

MeSH Terms

Conditions

Diabetic FootFoot UlcerDiabetes MellitusDepression

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesFoot DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavioral SymptomsBehavior

Study Officials

  • Marjolein M. Iversen, PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 19, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2022

Study Completion

December 1, 2024

Last Updated

April 21, 2023

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(3)