Your session is about to expire
← Back to Search
IPC + Standard Wound Care for Leg Ulcers (IPCOTT Trial)
N/A
Recruiting
Research Sponsored by Huntleigh Healthcare Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
IPCOTT Trial Summary
This trial will test if a new device (WoundExpress) can help heal leg ulcers, which usually take 3-4 months to heal with existing treatments.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from using the IPC device may include discomfort at the site of application and skin irritation under the garment. There's also a low risk of worsening any existing skin infections due to pressure.
IPCOTT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been using compression therapy for my ulcer and will continue to do so.
Select...
I can use and connect a special garment to a pump by myself for 2 hours every day for 16 weeks.
Select...
I have a hard-to-heal wound on my lower limb due to poor blood flow.
Select...
I am 18 years old or older.
Select...
My wound hasn't healed by at least 25% in the last month despite proper treatment.
IPCOTT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the effect of thigh administered IPC on the healing of lower limb wounds of venous or mixed etiology
Secondary outcome measures
Assess patient acceptability of IPC therapy
Assess safety of IPC therapy
Assess the cost effectiveness of IPC as a treatment for venous and mixed etiology leg ulcers
+3 moreIPCOTT Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard Wound Care plus IPCExperimental Treatment1 Intervention
Patients receiving gold standard compression therapy plus IPC (WoundExpress)
Group II: Standard Wound Care AloneExperimental Treatment1 Intervention
Patients receiving gold standard compression therapy for venous or mixed etiology ulcers
Find a Location
Who is running the clinical trial?
Huntleigh Healthcare LtdLead Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled
SerenaGroup, Inc.NETWORK
21 Previous Clinical Trials
1,676 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 severe hardening or blockage of my arteries.I have been using compression therapy for my ulcer and will continue to do so.My wound is either less than 2 months old or over 5 years old.I have been diagnosed with cancer.Your thigh is larger than 90cm around when measured with a garment.My recent HbA1c level was above 8.5.I have or might have blood clots or severe skin infections.I can use and connect a special garment to a pump by myself for 2 hours every day for 16 weeks.I am getting standard wound care that will not stop because of the study.I will not miss more than five days of therapy for any reason.My leg ulcers are not caused by vein problems and I don't have severe artery disease that compression would worsen.I am currently using additional treatments like heat or special dressings for my wound.I don't have skin issues that would worsen with a thigh garment.I have a hard-to-heal wound on my lower limb due to poor blood flow.My wound is larger than 100 square centimeters.I am 18 years old or older.I am using or willing to use birth control during the study.My wound hasn't healed by at least 25% in the last month despite proper treatment.I have severe heart failure or conditions worsened by fluid increase.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Wound Care plus IPC
- Group 2: Standard Wound Care Alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study still recruiting participants?
"This research study, which was initially advertised on December 1st 2022 and last modified on the 20th of that same month, is still actively recruiting patients."
Answered by AI
What is the maximum number of participants that can partake in this research?
"Affirmative. The clinicaltrials.gov website confirms that this investigation is currently searching for patients to participate, with the initial post being dated December 1st 2022 and the most recent update done on December 20th 2022. 160 volunteers are needed from one single medical centre."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger