Management of Diabetic Foot Ulcer by Electromagnetic Stimulator Therapy at The Townsville Hospital –A Pilot Study

Not Applicable

Recruiting

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

• Registration Number: ACTRN12617000181303
• Lead Sponsor: The Townsville Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-02
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Diabetes age >18 years
2. Stable documented diabetic foot ulcer of full-thickness skin defect requiring >14 days of healing.
3. Exclusion of other etiologies of foot ulcer.

Exclusion Criteria

1. Current index foot ulcer of any non-diabetic pathophysiology (e.g. rheumatoid, radiation-related, vasculitis-related, calciphylaxis, or dystrophic calcinosis cutis, etc.).
2. Any major surgery up to 4 weeks prior to the day of enrolment or any planned surgery prior to study completion including any major surgical intervention for the diabetic foot ulcer.
3. Significant medical conditions that potentially impair wound healing and/or alter the concentration of serum immune markers including hepatic, respiratory or cardiac failure, aplastic anemia, autoimmune diseases (e.g. Lupus erythematodes, scleroderma, etc.), chronic inflammatory diseases (e.g. inflammatory bowel disease, inflammatory or rheumatoid arthritis, etc.) and any active malignancies including cancerous or pre-cancerous lesions in the ulcer area other than basal cell carcinoma.
4. Treatment with normothermic or hyperbaric oxygen therapy.
5. Skin and dermal substitutes within 30 days prior to study enrolment.
6. Enzymatic debridement treatment.
7. Participation in any other clinical trial.
8. Subjects with pacemaker or implantable defibrillators
9. Inability to comply with study protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete or partial foot ulcer healing to be assessed fortnightly using specialized 3-D camera. An ulcer is considered completely healed when it is fully covered by epithelial regeneration and remained so until the next visit in the study. Partially healed ulcer is defined as any reduction in ulcer surface area during the period of the study.<br>[Fortnightly assessment at the time of treatment for the 12-week study period]

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who achieve a significant (20%) reduction of serum levels if interleukin 6 (IL-6)[Completion of the 12-week study]