Clinical and Economic Impact of Telemedicine in Management of Diabetes Foot Ulcer in Rural/Remote areas of North Queensland: A Pilot Study

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer; Metabolic and Endocrine - Diabetes; Skin - Other skin conditions

• Registration Number: ACTRN12615001215516
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients meeting the following inclusion criteria will be eligible to enter the study:

1. Diabetic foot ulcer of full-thickness skin defect requiring more than 14 days of healing.
2. Lives >50 km from The Townsville Hospital.
3. Exclusion of other etiologies of foot ulcer.

Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study:

1. Clinically significant lower-extremity ischemia (as defined by an ankle/brachial index of <0.65).
2. Planned surgical intervention for the diabetic foot ulcer.
3. Significant medical conditions that would impair wound healing will also be excluded from the study. These conditions include hepatic, respiratory or cardiac failures, aplastic anemia, scleroderma and malignancy, treatment with immunosuppressive agents or steroids.
4. Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis-related ulcers, calciphylaxis or dystrophic calcinosis cutis).
5. Active malignancy other than basal cell carcinoma as well as subjects with cancerous or pre-cancerous lesions in the ulcer area.
6. Inability to comply with study protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Partial or complete closure of foot ulcer will be assessed using specialized 3-D camera.[Healing rate: Week 1 will be compared with week 12]

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who achieve a significant (20%) reduction of serum levels of interleukin 6 (IL-6)[The IL-6 will be compared at week 1 and week 12]