Intermittent Pneumatic Compression of the Thigh

NCT05659394 | Completed DMC FDA Device

• 1 other identifier: 1341779
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 5

Brief Summary

Study Summary A leg ulcer is a long-lasting (chronic) sore that takes more than two weeks to heal. The majority of leg ulcers are caused either by problems with the veins in the legs; these are called 'venous leg ulcers' (VLU), or a combination of both venous and arterial disease which affects the veins and arteries in the leg; these are called 'mixed aetiology ulcers'(MLU). Venous and mixed aetiology leg ulcers are usually treated by applying a simple non-stick dressing to the ulcer with a firm compression bandage applied on top. These bandages are designed to squeeze the legs and encourage blood flow towards the heart. Before this treatment starts, a patient may undergo tests to check the flow of blood in the leg arteries is adequate. This ensures that compression bandaging can be safely applied to assist wound healing without compromising arterial blood flow. Most venous and mixed aetiology leg ulcers heal within three to four months if they're treated by a healthcare professional trained in compression therapy for leg ulcers. However, some ulcers can be more problematic and may persist for many months or even years despite being treated with the gold standard treatment of compression bandages. We therefore 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. IPC consists of a sleeve or garment which is applied to the leg. The sleeve is connected to a pump which gently inflates and then deflates it to squeeze the leg in a massage like manner. The IPCOTT study aims to find out if a new IPC device, known as the WoundExpress can help to heal leg ulcers. The WoundExpress has a sleeve that patients put around the thigh, like the one applied to the arm when people have their blood pressure taken. Users need to be either sitting with their legs raised or lying down when using the device. Pressing the 'start' button on the pump causes the sleeve to automatically inflate with air for 2 minutes, until it reaches a pressure of 60 mm/Hg (this is low compared to the pressure used when measuring blood pressure; most patients find it very gentle and comfortable). After the 2-minute inflation, the sleeve will automatically deflate for another 2 minutes, where no compression is applied to the thigh. These 4-minute inflation and deflation cycles will repeat whilst the device is in use. People who take part in the study will be randomly allocated to Group A or Group B. Patients in Group A will continue to receive their usual wound care but will also be provided with a WoundExpress device to use for 2 hours per day for a 16-week period. Patients in Group B will continue to receive their standard wound treatment only for the 16-week study period (patients in Group B will be offered the chance to use the WoundExpress device for a 16-week period after the study has ended). All patients taking part in the study will be asked to attend their Wound Clinic for a study review once every two weeks during the study period. At these visits, a research nurse will take measurements and photographs of the ulcer(s) and participants will also be asked some questions about how they have been feeling since using the device. Patients who have been given a WoundExpress device will also be asked to keep a diary recording when they use the device and how they found it. When the study is complete, results will be analyzed to find out if there was any difference in ulcer healing rates between Group A and Group B.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Determine the effect of thigh administered IPC on the healing of lower limb wounds of venous or mixed etiology

  Assess percentage change to wound surface area of the reference ulcer following a 16-week intervention period as assessed by the percentage of change in wound surface. This will be calculated using the measurements from wound photographs and by dividing the change by the baseline area. A percentage below zero will indicate an increase in wound size and a percentage above zero indicates a reduction in wound size at week 16 compared with baseline.

  16 weeks

Secondary Outcomes (6)

• Assess the effect of IPC on patient experience of wound related pain

  16 weeks

• Assess the effect of IPC on patient quality of life

  16 weeks

• Assess patient acceptability of IPC therapy

  16 weeks

• Assess the cost effectiveness of IPC as a treatment for venous and mixed etiology leg ulcers

  16 weeks

• Determine the proportion of patients with wound closure at week 16

  16 weeks

Study Arms (2)

Standard Wound Care Alone

OTHER

Patients receiving gold standard compression therapy for venous or mixed etiology ulcers

Other: Standard Wound Care Alone

Standard Wound Care plus IPC

OTHER

Patients receiving gold standard compression therapy plus IPC (WoundExpress)

Device: Stand Wound Care plus IPC

Interventions

Standard Wound Care Alone OTHER

gold standard compression therapy

Standard Wound Care Alone

Stand Wound Care plus IPC DEVICE

gold standard compression therapy plus IPC (WoundExpress)

Standard Wound Care plus IPC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huntleigh Healthcare Ltd: lead
• SerenaGroup, Inc.: collaborator

Study Sites (5)

Royal Research

Hollywood, Florida, 33021, United States

Location

Three Rivers Wound and Hyperberic

North Port, Florida, 34289, United States

Location

Wound Care of Tulsa

Tulsa, Oklahoma, 74135, United States

Location

SerenaGroup

Monroeville, Pennsylvania, 15146, United States

Location

SerenaGroup Research

Austin, Texas, 78701, United States

Location

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MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The IPCOTT study is a parallel global multicentre, pragmatic, open, randomised controlled trial of IPC (2hrs daily) plus standard wound care vs. standard wound care alone.

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: January 25, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data

Locations

US (5)