Preliminary Investigation of a Smart Compression Therapy Prototype

NCT ID: NCT05610241

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-04
• Study Completion Date: 2023-03-21

Brief Summary

Compression wraps treat venous leg ulcers when applied correctly. Often, clinicians apply the wraps at the wrong compression, or the wrap loosens, stopping clinical benefits. The study aims to show the feasibility of a smart compression prototype to maintain a set compression level in healthy volunteers. Each volunteer will wear the prototype device on one leg and a standard compression wrap on the other. Volunteers will pump their calves, walk, lie down, and stand at zero, one, and four hours. A pressure sensor placed over each calf will record the compression level during the activities. Volunteers will provide subjective feedback on each device concerning comfort and usability. After four hours, researchers will remove the standard wrap. Volunteers will use the prototype device during daily activities for three days. During the three days, the volunteers will complete a daily journal. The journal will capture the user experience and time the volunteer used the device. A final site visit allows researchers to conduct exit interviews and download the history of applied compression. Researchers will use the data to show that the prototype device maintains therapeutic compression and prove the usability of the device.

Conditions

Venous Leg Ulcer; Venous Insufficiency of Leg

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Compression Therapy System Prototype

Identifies legs randomized to receive the experimental intervention

Group Type: EXPERIMENTAL

Compression Therapy System Prototype

Intervention Type: DEVICE

A device designed to deliver compression therapy at a pre-set level to the lower leg for legs with a circumference between 30-50 cm. The device provides compression through a series of three air bladders and is controlled by a battery-powered electronic module that controls compression levels by monitoring bladder pressure.

Coban 2 (2 Layer Compression Wrap)

Identifies the legs randomized to receive the control intervention

Group Type: ACTIVE_COMPARATOR

Standard Compression

Intervention Type: DEVICE

Coban 2 represents the standard of care 2-layer compression wrap used to treat venous leg ulcers. The device consists of a comfort layer and a compression layer. A clinician applies the device to establish compression therapy.

Interventions

Compression Therapy System Prototype

A device designed to deliver compression therapy at a pre-set level to the lower leg for legs with a circumference between 30-50 cm. The device provides compression through a series of three air bladders and is controlled by a battery-powered electronic module that controls compression levels by monitoring bladder pressure.

Intervention Type: DEVICE

Standard Compression

Coban 2 represents the standard of care 2-layer compression wrap used to treat venous leg ulcers. The device consists of a comfort layer and a compression layer. A clinician applies the device to establish compression therapy.

Intervention Type: DEVICE

Other Intervention Names

2 Layer Compression Wrap; 2 Layer Compression Bandage; Coban 2

Eligibility Criteria

Inclusion Criteria

• Intact, healthy skin at the application site in both legs
• Calf circumferences to be within 30 - 50 cm between the medial and lateral head of the gastrocnemius
• Able to understand the Patient Information Leaflet
• Willing and able to give informed consent
• Able to wear, don and doff the compression device without external help
• Willing and able to follow the requirements of the clinical investigation plan
• Presence of pedal pulses identified by hand-held Doppler (8 MHz)
• Ankle Brachial Pressure Index between 0.9 and 1.4

Exclusion Criteria

• History of signs of previous deep or superficial vein thrombosis/pulmonary embolism
• Peripheral artery disease ( or ABPI < 0.90 or > 1.4), critical limb ischemia, or arterial ulceration
• Varicose veins, varicose eczema, or venous ulceration
• Chronic lower limb swelling, edema, lymphedema, or lipoedema
• Recent surgery within the last three months (such as abdominal, gynecological, hip or knee replacement, or lower limb) that may affect the study in the opinion of the investigator
• Recent trauma to a lower limb within the last three months
• Chronic obesity (defined as BMI index >40 kg/m^2)
• Diabetes mellitus
• Pregnancy
• A pulse rate of fewer than 40 beats/minute
• A sitting systolic blood pressure of > 180 and < 100 mmHg and/or a sitting diastolic pressure of > 100 mmHg
• Any significant illness during the previous four (4) weeks
• Participation in any clinical study during the eight (8) weeks preceding the screening period
• Any evidence of edema or pain
• Skin diseases, including wounds on the feet or lower limbs
• Any history of heart, liver, kidney, or vascular diseases
• History of having been prescribed compression stockings for treatment of a medical condition
• Serious allergies
• Dermatitis with oozing or fragile skin
• Persons currently using NSAID, Diuretics, Vasodilators, and steriods
• Drivers and Driving Professionals

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: collaborator

Tyndall National Institute

UNKNOWN

Sponsor Role: collaborator

Enterprise Ireland

OTHER_GOV

Sponsor Role: collaborator

DeRoyal Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Declan Patton, PhD

Role: STUDY_DIRECTOR

RCSI University of Medicine and Health Sciences

Locations

RCSI Education and Research Centre

Dublin, , Ireland

Countries

Ireland

Other Identifiers

CI52248

Identifier Type: -

Identifier Source: org_study_id