Intermittent pneumatic compression of the thigh for the treatment of lower limb wounds
| ISRCTN | ISRCTN77093550 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77093550 |
| IRAS number | 285979 |
| ClinicalTrials.gov number | NCT05659394 |
| Secondary identifying numbers | IRAS 285979 |
- Submission date
- 04/09/2020
- Registration date
- 15/10/2020
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Most leg ulcers are caused by problems with the veins in the legs and treatment involves wearing firm compression bandages which squeeze the legs and help blood flow to the heart. Unfortunately, some ulcers can be problematic and may persist for months or even years despite being treated with the gold standard treatment of compression bandages. Therefore there is a need to find more ways of helping these problematic ulcers to heal.
Intermittent Pneumatic Compression (or IPC) is another way of compressing legs to try and improve the circulation. The IPCOTT study aims to find out if a new IPC device, known as the WoundExpressTM, can help to heal leg ulcers.
Who can take part?
Most people who have a leg ulcer that is caused by problems with the veins (but not the arteries) will be eligible to take part.
What does the study involve?
Upon entry to the study, participants will be randomly allocated to one of two groups. Group A will be provided with an IPC (WoundExpress) device to use in their home environment for 2 hours daily for the 16-week duration of the study (in addition to continuing to receive their standard wound care). Group B will continue to receive their usual wound care for the 16-week duration of the study. Throughout the 16-week study period, participants will be invited to attend their wound clinic once every two weeks where their leg ulcer and general health will be reassessed.
What are the possible risks and benefits of taking part?
Use of the IPC device may possibly help to reduce the size of leg ulcers and may lessen any ulcer related pain. It is hoped that the information that is gained from this study will help to improve future treatments for patients with leg ulcers.
There are currently no known side effects associated with the use of the IPC (WoundExpress) device.
Where is the study run from?
1. The Welsh Wound Innovation Centre (UK)
2. Accelerate CIC (UK)
3. St. Maria Hilf Krankenhaus, Bochum (Germany)
4. Charité - Universitätsmedizin Berlin (Germany)
5. Karolinska University Hospital, Stockholm (Sweden)
When is the study starting and how long is it expected to run for?
November 2019 to August 2024
Who is funding the study?
1. Huntleigh Healthcare
2. The Accelerate programme which is co-funded by the European Regional Development Fund, through the Welsh Government
Who is the main contact for the study?
Dr Kerry Nyland
Kerry.nyland@arjo.com
Contact information
Public, Scientific
Huntleigh Healthcare Ltd
35 Portmanmoor Road
Cardiff
CF24 5HN
United Kingdom
| Phone | +44 (0) 2920 447 038 |
|---|---|
| Kerry.nyland@arjo.com |
Study information
| Study design | Multicentre interventional open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice, Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Intermittent Pneumatic Compression of the Thigh for the Treatment of lower limb wounds (IPCOTT): a randomised control trial of IPC plus standard care vs. standard care alone |
| Study acronym | IPCOTT |
| Study objectives | The addition of thigh-applied, intermittent, pneumatic, compression therapy to standard wound care, for the treatment of venous leg ulcers, will improve ulcer healing. |
| Ethics approval(s) | Approved 26/11/2020, Wales REC 3 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB; +44 (0)2920 230457; Wales.REC3@wales.nhs.uk) |
| Health condition(s) or problem(s) studied | Treatment of leg ulceration of venous and mixed aetiology |
| Intervention | Following a baseline assessment (which will include the collection of information relating to past medical history, current medications, wound history, current wound treatment, and wound measurement and photography), patients will be randomly assigned to treatment groups (group A and group B) using random permuted blocks within each centre. Wound size (≤30cm2, >30cm2) and duration (≤12 months, >12 months) will be stratification factors. An online software application (provided by Sealed Envelope Ltd) will be used for this purpose. Group A will be the IPC group who will receive a WoundExpress IPC device to be used for two hours daily in the participant's own homes for a 16 week study period. During this time, participants in group A will also continue to receive their standard wound care. Participants in group B will receive their standard wound care only for the duration of the study. All participants will attend a follow-up appointment every two weeks where wound reassessment including measurement and photography and adherence to the intervention (for participants in group A) will be undertaken. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | WoundExpress a thigh applied intermittent pneumatic compression device |
| Primary outcome measure | 1. Percentage reduction in wound surface area from baseline to week 16 measured using an IPad and InSight® wound imaging software at baseline, 0, 2, 4, 6, 8, 10, 12, 14, and 16 weeks. A wound visual assessment will also be done documenting the condition of the wound bed, wound margin, condition of surrounding skin, and level of exudate. For the purpose of this trial, healing is defined as: ‘complete, full, 100% re-epithelialisation or closure without discharge, drainage/scab’. |
| Secondary outcome measures | 1.Patient-reported wound-related pain according to a visual analogue score (VAS) at baseline, 0, 2, 4, 6, 8, 10, 12, 14, and 16 weeks 2. Patient-reported quality of life according to the Cardiff Wound Impact Schedule at baseline, 0, 2, 4, 6, 8, 10, 12, 14, and 16 weeks 3. Proportion of patients with complete wound healing during study 16 week period assessed using an IPad and InSight® wound imaging software at baseline, 0, 2, 4, 6, 8, 10, 12, 14, and 16 weeks |
| Overall study start date | 01/11/2019 |
| Completion date | 07/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Total final enrolment | 136 |
| Key inclusion criteria | Current inclusion criteria as of 31/01/2023 (updated 04/09/2023): 1. Age ≥18 years 2. Presence of at least one hard-to-heal*, venous or mixed (of both venous and arterial origin) aetiology lower limb wound 3. ABPI ≥0.6, or, where an ABPI measure is not viable, use of locally-approved alternative assessments to rule out significant peripheral arterial disease i.e. Doppler ausculation, toe pressure assessment (Absolute Toe Pressure ≥40mmHg ) or arterial imaging 4. Has received high static compression therapy (in the form of bandages, wraps or hosiery) during the preceding 4 weeks and is willing to continue receiving appropriate static compression therapy for their ulcer aetiology for the duration of the study 5. Receiving standard wound care as per investigator discretion which will continue regardless of study participation 6. Able and willing to give informed consent for participation in the study 7. Able to self-apply IPC garment (supplied) and connect to an electrically operated pump at home for 2 hours daily for a 16-week period 8. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo a pregnancy test at screening _____ Previous inclusion criteria from 05/03/2021 to 04/09/2023: 1. Age ≥18 years 2. Presence of at least one lower limb wound with venous aetiology, which is hard to heal. For the purpose of this trial, hard to heal is defined as a failure of the wound to progress towards healing (as indicated by a decrease in surface area by ≥25%) in the preceding month, despite appropriate and adequate compression therapy. 3. ABPI ≥ 0.8, or, where an ABPI measure is not viable, use of locally-approved alternative assessments to rule out peripheral arterial disease i.e. Doppler ausculation, toe pressure assessment (TBI > 0.5) or arterial imaging 4. Has received high static compression therapy (in the form of bandages, wraps, or hosiery) during the preceding 4 weeks and is willing to continue receiving high static compression therapy for the duration of the study 5. Able and willing to give informed consent for participation in the study 6. Able to self-apply IPC garment (supplied) and connect to an electrically operated pump at home for two hours daily for a 16-week period _____ Previous inclusion criteria: 1. Age ≥18 years 2. Presence of at least one lower limb wound with venous aetiology, which is hard to heal. For the purpose of this trial, hard to heal is defined as a failure of the wound to progress towards healing (as indicated by a decrease in surface area by ≥25%) in preceding month, despite appropriate and adequate compression therapy. 3. Has received high static compression therapy (in the form of bandages, wraps, or hosiery) during the preceding 4 weeks and is willing to continue receiving high static compression therapy for the duration of the study 4. Able and willing to give informed consent for participation in the study 5. Able to self-apply IPC garment (supplied) and connect to an electrically operated pump at home for two hours daily for a 16-week period |
| Key exclusion criteria | Current exclusion criteria as of 31/01/2023 (updated 04/09/2023): 1. Wound surface area ≥100cm² 2. Wound duration ≤2 months or ≥ 5 years 3. Diabetic patients with recentƗ HbA1c >8.5 4. Known or suspected deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis and acute infections of the skin, such as cellulitis 5. Decompensated/severe congestive cardiac failure, pulmonary oedema associated with significant limb oedema or any condition where an increase of fluid to the heart may be detrimental 6. Severe arteriosclerosis or other ischaemic vascular disease 7. Leg ulcers without a venous component to their aetiology (e.g., arterial or rheumatoid) or significant peripheral vascular disease which contraindicates compression (ABI < 0.6 or Absolute Toe Pressure <40 mmHg) 8. Known malignancy 9. Patient receiving any other adjunctive wound therapy such as heat, topical negative therapy, biotherapy 10. Current participation in any other clinical trial 11. Patient likely to miss more than 5 days of therapy (e.g. for planned holiday) 12. Thigh circumference >90 cm (maximum garment size) 13. Any wounds, infection or dermatological conditions that would be adversely affected by placement of the thigh garment 14. Subject is pregnant or breastfeeding _____ Previous exclusion criteria from 05/03/2021 to 04/09/2023: 1. Wound surface area ≥100 cm² 2. Wound duration ≤2 months or ≥5 years 3. Diabetic patients with recent HbA1c >8.5 4. Known, or suspected, deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis, or acute infections of the skin, such as cellulitis 5. Decompensated/severe congestive cardiac failure, pulmonary oedema associated with significant limb oedema, or any condition where an increase of fluid to the heart may be detrimental 6. Severe arteriosclerosis or other ischaemic vascular diseases 7. Leg ulcers of non-venous aetiology (e.g., arterial or rheumatoid) or significant peripheral vascular disease which contraindicates full compression (ABPI < 0.8 or TBI ≤ 0.5) 8. Known malignancy 9. Receiving any other adjunctive wound therapy such as heat, topical negative therapy, biotherapy 10. Current participation in any other clinical trial 11. Likely to miss more than five days of therapy (e.g. for planned holiday) 12. Thigh circumference >73 cm (maximum garment size) _____ Previous exclusion criteria: 1. Wound surface area ≥100 cm² 2. Wound duration ≤2 months or ≥5 years 3. Diabetic patients with recent HbA1c >8.5 4. Known, or suspected, deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis, or acute infections of the skin, such as cellulitis 5. Decompensated/severe congestive cardiac failure, pulmonary oedema associated with significant limb oedema, or any condition where an increase of fluid to the heart may be detrimental 6. Severe arteriosclerosis or other ischaemic vascular diseases 7. ABPI ≤0.8 or ≥1.3 8. Known malignancy 9. Receiving any other adjunctive wound therapy such as heat, topical negative therapy, biotherapy 10. Current participation in any other clinical trial 11. Likely to miss more than five days of therapy (e.g. for planned holiday) 12. Thigh circumference >73 cm (maximum garment size) |
| Date of first enrolment | 08/03/2021 |
| Date of final enrolment | 31/03/2024 |
Locations
Countries of recruitment
- England
- Germany
- Sweden
- United Kingdom
- United States of America
- Wales
Study participating centres
Ynysmaerdy
Pontyclun
Rhondda Cynon Taf
Pontyclun
CF72 8UX
United Kingdom
St Joseph’s Hospice
Mare St
Hackney
London
E8 4SA
United Kingdom
Bochum
44805
United Kingdom
Geriatrics Research Group
Nursing Research Group
Reinickendorfer Str. 61
Berlin
13347
Germany
Stockholm
SE-171 76
Sweden
Rake Lane
North Shields
NE29 8NH
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Monroeville
15146
United States of America
North Port
34289
United States of America
Tulsa
74135
United States of America
Hollywood
33021
United Kingdom
Phoenix
85004
United States of America
Sponsor information
Industry
35 Portmanmoor Road
Cardiff
CF24 5HN
Wales
United Kingdom
| Phone | +44 (0)2920 485885 |
|---|---|
| kerry.nyland@arjo.com | |
| Website | https://www.huntleigh-diagnostics.com/ |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results will be published in a high impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
20/01/2025: The intention to publish date was changed from 01/01/2025 to 01/07/2025.
29/08/2024: A public contact was removed.
28/08/2024: The following changes were made:
1. The scientific contact was removed.
2. The total final enrolment was added.
3. The overall study end date was changed from 15/08/2024 to 07/08/2024.
4. The intention to publish date was changed from 01/12/2024 to 01/01/2025.
08/04/2024: ClinicalTrials.gov number added.
04/09/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2023 to 31/03/2024.
2. The overall study end date was changed from 31/01/2024 to 15/08/2024.
3. Three Rivers Wound and Hyperbaric Center, Wound Care of Tulsa, Royal Research and Titan Research
were added as study participating centres.
4. The inclusion and exclusion criteria were updated.
5. The condition was changed from 'Treatment of leg ulceration of venous aetiology' to 'Treatment of leg ulceration of venous and mixed aetiology'.
04/05/2023: The following changes were made to the trial record:
1. Mid Yorkshire Hospitals NHS Trust and SerenaGroup Monroeville were added to the trial participating centres.
2. USA was added to the countries of recruitment.
3. The intention to publish date was changed from 01/06/2023 to 01/12/2024.
03/05/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/05/2022 to 30/09/2023.
2. The overall trial end date was changed from 28/02/2023 to 31/01/2024.
10/02/2023: Contact details updated.
06/02/2023: The study setting has been changed from ‘Other’.
30/08/2022: The sponsor contact email has been changed.
17/05/2022: One of the study contacts has been removed and another added.
10/05/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2022 to 28/02/2023.
2. The trial participating centre
3. The plain English summary was updated to reflect these changes.
05/03/2021: The following changes were made to the trial record:
1. The ethics approval was added.
2. The inclusion criteria were changed.
3. The exclusion criteria were changed.
4. The trial participating centres
5. The recruitment start date was changed from 01/11/2020 to 08/03/2021.
6. The recruitment end date was changed from 30/09/2021 to 30/05/2022.
7. The plain English summary was updated to reflect these changes.
15/10/2020: Trial’s existence confirmed by Cardiff University School of Medicine.
