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

A single blinded randomised controlled trial to determine the clinical effect size and client concordance following eight weeks using a portable electrostimulation device among people with an active leg ulcer who do not tolerate moderate to high compression therapy

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000249651

Enrollment

Registered

2014-03-10

Start date

2014-04-03

Completion date

2014-12-25

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Leg ulcers have a big impact on the lives of those affected. Compression therapy is recommended to help heal an ulcer but many people find it difficult to wear high or moderate compression therapy products. Electric stimulation therapy has been used by physiotherapists to improve circulation in the legs—the goal of compression therapy. This study has been developed as a small clinical trial that will see if electric stimulation therapy can help heal ulcers and will help determine if further large clinical trials are worthwhile.

Interventions

Participants will be instructed to self-administer Electrostimulation Therapy using a small portable device four times daily for 20 minute sessions, over a period of 8 weeks. The device will be pre-set to a single, non-adjustable specific low frequency found between 1-2 Hertz, a current that specifically targets smooth muscle to promote stimulation of arterial, venous and lymphatic systems. Adherence will be monitored using a self-report participant treatment log.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results