Pilot Study: Do Wounds Heal Faster When Using Electric Stimulation Therapy

Phase 2

• Conditions: Venous leg ulcers; Skin - Other skin conditions; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12614000249651
• Lead Sponsor: BodyFlow International Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Client has an existing leg ulcer with either primary venous or lymphedema as its primary aetiology
2. Client is appropriate for, and the best practice treatment would involve the highest compression therapy available (+40mmHg)
3. Client is currently using (1) no compression therapy or (2) low compression therapy (less than 18mmHg)
4. Client has received wound care education specifically promoting the use of compression therapy
5. The client or carer/legal guardian is able to provide informed consent to participate in the study
6. Client has had a Doppler ultrasound in the last 12 weeks
7. Ankle Pressure Brachial Index is between greater than or equal to 0.8 and less than or equal to 1.2

Exclusion Criteria

1. Client is using moderate or high compression therapy (equal to or greater than 18mmHg) for any period of the day for one or more days of the week.
2. Client is unable to or does not have someone who can physically implement the Electrostimulation Therapy.
3. Client is unable to or does not have someone who can take low compression garments (for those currently wearing compression) on and off in between Electrostimulation Therapy treatments
4. Client has an existing diagnosis of Deep Vein Thrombosis (DVT)
5. Client has an implanted cardiac device such as a permanent pace-maker or internal defibrillator
6. Diagnosed with an active malignant disease
7. Client is pregnant
8. Client has signs of clinical infection in their ulcer
9. Client has a known reaction to adhesive chemicals such as those used on dressings
10. Client is assessed by their clinician as having fragile skin that is at risk of damage when removing the adhesive pads
11. Client has one of the following medical diagnoses: hypothyroidism, hyperthyroidism, congestive cardiac failure, or hypertension

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound healing rate for the ‘study wound’ (determined as a daily healing rate from total wound surface tracings quantified using VisiTrak tracings and VisiTrak annotating board)<br>[Baseline, and at 2, 4, 6 and 8 weeks after intervention commencement.]