Is the healing rate in diabetes related foot ulcers improved with low frequency ultrasonic debridement versus non-surgical sharps debridement? A randomised control trial.

Not Applicable

• Conditions: Diabetes related foot ulceration.; Skin - Other skin conditions; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12612000490875
• Lead Sponsor: ucia Michailidis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Equal to and greater that 30 years of age
- Able to provide informed consent
- Wounds greater than 1cm squared in total area
- Wounds present for greater than 1 month
- Vascular assessment: Palpable pedal pulses OR toe pressure equal to or greater than 45mmHg OR meeting stages 0 (asymptomatic), 1 (mild claudication) and 2 (moderate claudication at 200m) of the Rutherford Classification for peripheral arterial disease
- Infected ulcers being appropriately managed
- Ulcers meeting The University of Texas wound classification criteria: A1, A2, A3 (wounds of varying depth without infection or ischaemia) and B1, B2, B3 (wounds of varying depth with infection only)

Exclusion Criteria

- Participants taking immunosuppressive medication
- Known allergies to wound dressing products
- Pre-existing ulcer pain preventing either type of debridement
- Vascular assessment: meeting stages 3 (severe classification), 4 (rest pain), 5 (ischaemic ulceration not exceeding ulcer of the digits of the foot) and 6 (severe ischaemic ulcers or frank gangrene) of the Rutherford Classification for peripheral arterial disease
- Dry gangrenous ulcers
- Fungating ulcers
- Malignant ulcers
- Those meeting the University of Texas Wound Classification Criteria: A0, B0, C0, D0 (pre or post-ulcerative lesion with complete epithelialisation, with or without infection and ischaemia), C1, C2, C3 (wounds with varying depth and ischaemia only), D1, D2, D3, (wounds with varying depth with ischaemia and infection)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study aims to compare healing rates for diabetes related foot ulcers using non-surgical sharps debridement versus low frequency ultrasonic debridement.[Wounds will be measured following each treatment to determine total ulcer area in centimetres squared until the time of healing or completion of the study. Percentage of necrotic tissue is no longer being included in this study.]

Secondary Outcome Measures

Name	Time	Method
Economic evaluation: cost effectiveness analysis of both direct and indirect health care costs will be determined at the completion of the study.[1 week post final treatment.];Number of complications that resulted from either method of ulcer debridement including: <br>- Number of amputations required<br>- Number of surgical debridements required<br>- Number of infections developed[1 week post final treatment.];Wound pain assessment[All wounds will be assessed for pain using the visual analogue pain scale prior, during and after each treatment.];Cost utility analysis using a quality of life tool EQ-5D-5L. [This will be conducted at the initial assessment, mid way through the study (at 3 months) and again at the end of the study (at 6 months or when healed, whichever occurs first) for each participant.]