NCT01269502

Brief Summary

A randomised controlled pilot study on the feasibility of introducing a skin temperature device (Temp Touch) in secondary prevention of foot ulcers in people with diabetes who have had a foot ulcer in Norway.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

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, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

4.3 years

First QC Date

January 3, 2011

Last Update Submit

September 18, 2014

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

  • Recurrency of diabetic foot ulcer

    One year

Study Arms (2)

Skin temperature measurement

EXPERIMENTAL

Regular measurement of skin temperature on feet for one year

Device: "Temp Touch" Diabetica Solutions inc.

Active control

ACTIVE COMPARATOR

Daily inspection of feet for one year

Other: Inspection

Interventions

"Temp Touch" Diabetica Solutions inc.DEVICE

Daily measurement of skin temperature on feet for one year

Skin temperature measurement
InspectionOTHER

Inspection of feet daily for one year

Active control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous neuropathic diabetic foot ulcer

You may not qualify if:

  • Ankle/brachial index \< 0.7. Osteomyelitis, active Charcot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo university Hospital Ulleval

Oslo, Oslo County, 0407, Norway

Location

Related Publications (1)

  • Skafjeld A, Iversen MM, Holme I, Ribu L, Hvaal K, Kilhovd BK. A pilot study testing the feasibility of skin temperature monitoring to reduce recurrent foot ulcers in patients with diabetes--a randomized controlled trial. BMC Endocr Disord. 2015 Oct 9;15:55. doi: 10.1186/s12902-015-0054-x.

    PMID: 26452544DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Bente K Kilhovd, Md, PhD

    Oslo University Hospital Ulleval, Oslo, Norway

    PRINCIPAL INVESTIGATOR

  • Anita Skafjeld

    Oslo University Hospital, Ulleval, Oslo, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 4, 2011

Study Start

June 1, 2009

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

NO(1)