Condition category
Circulatory System
Date applied
16/05/2008
Date assigned
30/05/2008
Last edited
30/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jorge Vas

ORCID ID

Contact details

Pain Treatment Unit
Primary Healthcare Centre
Segovia s/n
Dos Hermanas
41700
Spain
jorgef.vas.sspa@juntadeandalucia.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EC0790215 / 0052/2007

Study information

Scientific title

Acronym

Study hypothesis

The combination of compression bandaging with simple, low-adherence dressings and acupuncture is more effective than when the same bandaging is employed in combination with special dressings or with simple, low-adherence dressings, but no sensory stimulation (acupuncture), with respect to the complete healing of venous leg ulcers.

Ethics approval

Andalusian Government Committee for Clinical Trials, Spain. Date of approval: 08/05/2007 (ref: acta 03/07)

Study design

Prospective, open, multicentre, cluster randomised trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Venous leg ulcer

Intervention

The participating primary healthcare centres will be randomly allocated to the following three groups:
Group A: Compression therapy + low-adherence, simple dressings + acupuncture
Group B: Compression therapy + special dressings
Group C: Compression therapy + low-adherence, simple dressings

Compression therapy (Groups A, B and C):
Compression therapy will be given to all the participants in the study. Once the patient has been examined and the ankle/arm index calculated by means of a Doppler scan, an evaluation will be made of the state of the skin and of the shape of the leg, after confirming the absence of neuropathology, arterial pathology and cardiac insufficiency. The bandaging will be of a class 3, high-compression multilayer type, following cleansing and application of the dressing, as follows:
1. With a 50% overlap, apply a cotton bandage in a spiral pattern from the base of the toes to just below the knee, without imposing any tension
2. Apply an elastic bandage in a spiral pattern, with 50% overlap and stretched to 50% of its extension, from the base of the toes to just below the knee
3. Apply a cohesive elastic bandage, with 50% overlap and stretched to 50% of its extension, from the base of the toes to just below the knee, and apply light pressure to ensure the adherence of the bandage. The oedema of the leg should be reduced by raising the limb for 15 minutes before applying compression.

Cleansing of the ulcer for the patients given low-adherence, simple dressings (Groups A and C):
1. Cleaning: with running water and mild soap, followed by careful drying
2. Debridement: if necrotic tissue or sloughing are observed, perform enzymatic debridement, which may be combined with excision debridement, if necessary
3. Managing infection: if infection is suspected, take a sample and begin treatment with Silvederma® for a maximum of 2 weeks. If a culture study confirms the infection, treat using oral antibiotics
4. Dressings: simple, low-adherence type (paraffin-impregnated tulle gras)

Topical treatment of the ulcer for the patients given special dressings (Group B):
1. Cleaning: with running water and mild soap, followed by careful drying
2. Debridement: if necrotic tissue or sloughing are observed, perform enzymatic debridement, which may be combined with hydrogel to favour autolysis. If necessary, excision debridement should be applied.
3. Managing infection: if infection is suspected, take a sample and begin treatment with silver dressings (hydrofibre or hydropolymer) for a maximum of 2 weeks. If a culture study confirms the infection, treat using oral antibiotics.
4. Dressings: Cover with hydropolymers. Use alginate or hydrofibre dressings if exudate must be controlled.

Sensory stimulation by acupuncture (Group A):
The nursing staff will be trained in the specific techniques of localisation, puncture and manipulation in order to apply acupuncture at the perilesional zone of the ulcer(s), in healthy skin, using 4-8 needles, and at 2 points located on either side of the tibial crest of the affected limb (Yinlingquan SP9 and Zusanli ST36). The sensorial stimulation sessions will be applied for the first 3 months of this treatment programme or until the ulcer has completely healed. If complete healing is not achieved in this period, the sessions may be prolonged for another 3 months, after which the sensorial stimulation treatment will be discontinued. For each session, the number of needles used and the exact location of their application will be recorded. A priori, the ulcer should be cleansed once weekly, the same frequency as the sensorial stimulation. Nevertheless, this may be increased or decreased, at the discretion of the nursing staff.

Duration of interventions: Interventions will continue until the ulcer is completely cured, except acupuncture which may be prolonged up to 6 months (maximum).
Total duration of follow-up: 12 months

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Time to complete healing.

Secondary outcome measures

1. Complete healing at 3 months after beginning treatment
2. Changes in the size of the surface area of the ulcer, assessed at 3, 6 and 12 months
3. Pain intensity measured on a visual analogue scale, assessed at 3, 6 and 12 months
4. Health-related quality of life, assessed using the 12-item Short Form health survey (version 2) at 3, 6 and 12 months

Overall trial start date

01/04/2008

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, no age limit
2. Patients with venous leg ulcers who request treatment by a medical professional (doctor or nurse) at one of the Primary Healthcare Clinics in the Sevilla-Sur Health District taking part in the study, with at least one active venous leg ulcer (open, clinical, etiological, anatomical, pathological classification [CEAP] C6) with a diameter exceeding 1 cm

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

375

Participant exclusion criteria

1. Arterial pathology (systolic pressure in the ankle of less than 80 mmHg or ankle/arm systolic index less than 0.8)
2. Diabetic ulcer of the foot, rheumatoid arthritis or systemic vasculitis
3. Use of anticoagulants
4. Pregnancy

Recruitment start date

01/04/2008

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Pain Treatment Unit
Dos Hermanas
41700
Spain

Sponsor information

Organisation

Carlos III Health Institute (Spain)

Sponsor details

C/ Sinesio Delgado
6
Madrid
28029
Spain

Sponsor type

Research organisation

Website

http://www.isciii.es/htdocs/en

Funders

Funder type

Research organisation

Funder name

Carlos III Health Institute, Healthcare Research Fund (Project No. EC0790215) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Andalusian Regional Ministry of Health (Project No. 0052/2007) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes