Intermittent pneumatic compression of the thigh for the treatment of lower limb wounds
- Conditions
- Treatment of leg ulceration of venous and mixed aetiologyCirculatory SystemVenous ulcer
- Registration Number
- ISRCTN77093550
- Lead Sponsor
- Huntleigh Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 136
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
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 recentI 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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<br>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<br>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