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Clinical Trials/ACTRN12617000181303
ACTRN12617000181303Recruiting未知

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

The Townsville Hospital0 sites50 target enrollmentStarted: February 2, 2017Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Recruiting
Sponsor
Enrollment
50

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to o limit (—)
Sex
All

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.

Investigators

Sponsor
The Townsville Hospital

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