IPC + Standard Wound Care for Leg Ulcers

(IPCOTT Trial)

Recruiting at 4 trial locations

Overseen By Kerry Nyland, RN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Huntleigh Healthcare Ltd

Disqualifiers: Diabetes, DVT, Cardiac failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

136 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called WoundExpress to help heal stubborn leg ulcers. The device gently squeezes the thigh to improve blood flow, which can help ulcers heal faster. The study aims to see if WoundExpress makes a difference in healing.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must continue receiving standard wound care and compression therapy during the study.

What data supports the effectiveness of the treatment Intermittent Pneumatic Compression of the Thigh for leg ulcers?

Research shows that using Intermittent Pneumatic Compression (IPC) on the thigh helps heal leg ulcers, with 95% of patients in one study showing wound improvement. Additionally, IPC has been found to improve healing rates in venous ulcers, making it a promising option for managing leg ulcers. ^{1 2 3 4 5}

How is the treatment Intermittent Pneumatic Compression (IPC) for leg ulcers different from other treatments?

Intermittent Pneumatic Compression (IPC) is unique because it uses a mechanical device to apply pressure to the thigh, helping to improve blood flow and reduce swelling, which is different from standard treatments that often rely on compression bandages or stockings. ^{2 5 6 7 8}

Eligibility Criteria

Adults with chronic venous or mixed-origin leg ulcers, who've had unsuccessful healing despite compression therapy, can join. They must be able to use the IPC device at home for 2 hours daily over 16 weeks and continue standard wound care. Exclusions include severe vascular diseases, large or very old/new wounds, uncontrolled diabetes, recent serious cardiovascular events, current pregnancy or breastfeeding.

Inclusion Criteria

Your ankle-brachial index (ABPI) is at least 0.6, or if this test can't be done, you have been checked for peripheral arterial disease using other approved methods.

I have been using compression therapy for my ulcer and will continue to do so.

I can use and connect a special garment to a pump by myself for 2 hours every day for 16 weeks.

Exclusion Criteria

I have severe hardening or blockage of my arteries.

My wound is either less than 2 months old or over 5 years old.

I have been diagnosed with cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either standard wound care plus IPC or standard wound care alone for 16 weeks

16 weeks

Bi-weekly visits to the Wound Clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants in Group B are offered the chance to use the WoundExpress device for a 16-week period after the study has ended

16 weeks

Treatment Details

Interventions

• Intermittent Pneumatic Compression of the Thigh

Trial Overview The trial is testing if adding Intermittent Pneumatic Compression (IPC) using a thigh sleeve called WoundExpress improves healing of leg ulcers compared to standard wound care alone. Participants are randomly assigned to either receive the IPC device plus usual care or just usual care for a period of 16 weeks.

Participant Groups

Group I: Standard Wound Care plus IPC Experimental Treatment 1 Intervention

Patients receiving gold standard compression therapy plus IPC (WoundExpress)

Group II: Standard Wound Care Alone Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Huntleigh Healthcare Ltd

Lead Sponsor

Trials

3

Recruited

200+

SerenaGroup, Inc.

Collaborator

Trials

32

Recruited

3,900+

References

1. England pubmed.ncbi.nlm.nih.gov

A prospective pilot study of thigh-administered intermittent pneumatic compression in the management of hard-to-heal lower limb venous and mixed aetiology ulcers. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of two different intermittent pneumatic compression cycle settings in the healing of venous ulcers: a randomized trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Intermittent pneumatic compression improves venous ulcer healing. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Using a programmable pneumatic device with truncal therapy to facilitate wound healing: a case series. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Intermittent pneumatic compression for treating venous leg ulcers. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Intermittent pneumatic compression for treating venous leg ulcers. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Intermittent pneumatic compression for treating venous leg ulcers. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Intermittent pneumatic compression for treating venous leg ulcers. [2020]