3D Camera - Telemedical Foot Ulcer Treatment

NCT01870934 | Unknown DMC

• 2 other identifiers: OUH3D0112-08-00621
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel. The 3D photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. The camera was developed in close cooperation with TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.

Conditions

Diabetes Mellitus; Foot Ulcers

Keywords

Telemedicine; Diabetes; Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Comparison of 3D image and normal assessment of wounds

  outcome measure is assessed in 2013

Secondary Outcomes (1)

• Comparison of 3D and 2D image assessment of wounds

  november 2013

Study Arms (1)

Telemedicine, Diabetes, foot ulcer

Device: Camera

Interventions

Camera DEVICE

No real intervention, but a comparison of different methods including the new medical device 3D camera.

Telemedicine, Diabetes, foot ulcer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic foot ulcers patients

You may qualify if:

• Patients with diabetic foot ulcers, which has been the diagnosis, stratification (eg ischemia, neuropathy, etc.) and treatment according to current guidelines refer "Diabetic Foot Study Group". Age 18-90 years

You may not qualify if:

• Superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• Benjamin Schnack Rasmussen, M.D

  Odense University Hosptial

  PRINCIPAL INVESTIGATOR

• Knud Yderstræde, MD, Ph.d.

  Odense University Hospital

  STUDY CHAIR

Central Study Contacts

Benjamin Sc Rasmussen, M.D.

CONTACT

bsr@rsyd.dk

Benjamin Schnack Sc Rasmussen

CONTACT

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research responsible Chief Surgeon

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

DK (1)