Intermittent Pneumatic Compression of the Thigh

Launched by HUNTLEIGH HEALTHCARE LTD · Dec 12, 2022

Keywords

ClinConnect Summary

Clinical Problem:

A leg ulcer is defined as the loss of skin below the knee on the leg or the foot, which takes more than two weeks to heal. Leg ulcers are the most common wound type in the community in the UK with a prevalence rate of approximately of 0.45/1000 in men and 0.56/1000 in women, increasing to 8.29/1000 in men and 8.06/1000 in women aged over 85 years old. Leg ulcers of venous origin account for approximately 70% of individuals with leg ulcers, with 10-20% being due to a combination of venous and arterial disease, often referred to as mixed leg ulcers (MLU).

Leg ulceration re...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Presence of at least one hard to heal\*, venous or mixed (of both venous and arterial origin) aetiology lower limb wound
• • 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 auscultation, toe pressure assessment (Absolute Toe Pressure ≥40mmHg ) or arterial imaging
• • 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
• • Receiving standard wound care as per investigator discretion which will continue regardless of study participation
• • Able and willing to give informed consent for participation in study
• • 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
• • 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
• • Failure of wound to progress towards healing (as indicated by decrease in surface area by ≥ 25%) in preceding month, despite appropriate and adequate compression therapy.
• Exclusion Criteria:
• • Wound surface area ≥ 100cm2
• • Wound duration ≤ 2 months or ≥ 5 years
• • Diabetic patients with recent HbA1c \>8.5
• • Known or suspected deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis and acute infections of the skin, such as cellulitis
• • 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
• • Severe arteriosclerosis or other ischemic vascular disease
• • 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 \<40mmHg)
• • Known malignancy
• • Patient receiving any other adjunctive wound therapy such as heat, topical negative therapy, biotherapy
• • Current participation in any other clinical trial
• • Patient likely to miss more than five days of therapy (e.g. for planned holiday)
• • Thigh circumference \>90cm (maximum garment size)
• • Any wounds, infection or dermatological conditions that would be adversely affected by placement of the thigh garment
• • Subject is pregnant or breast-feeding
• • Ɨ within preceding 3 months