Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients

NCT02912858 | Withdrawn

• 1 other identifier: FKD-IPC-003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic venous leg ulcers (VLU) are painful, debilitating wounds that place a significant burden on the patient, their family, and healthcare resources. Treating VLU can present a significant challenge to clinicians, who currently have a limited range of treatments at their disposal. The mainstay of treatment is compression bandaging, ambulation and elevation at rest. In addition to the aforementioned, intermittent pneumatic compression has also been utilised1. When applied to the leg or foot intermittent pneumatic compression (IPC) devices intermittently inflate and deflate to increase venous return. These devices can be uncomfortable to wear, and compliance can be inhibited because of size, weight and external power source that limit the patient's mobility. In patients who cannot walk, or in those who are unable to tolerate compression bandaging, ulcers may deteriorate and never heal. Accordingly, there is a need for novel, alternative devices or strategies that can be used to complement or replace compression bandage therapy.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• The lower limb blood flow between gekoTM plus R-2 and IPC devices in VLU patients will be assessed.

  Duplex ultrasound of the femoral vein and artery will be performed with bilateral recording of blood flow velocity. After 10 minutes activation of either geko™ or IPC and after the 10 minutes the devices will swapped over and measurements performed. All measurements to be carried out in triplicate.

  3 months

Secondary Outcomes (1)

• Adverse events assessments

  3 months

Study Arms (1)

geko plus R-2

EXPERIMENTAL

neuromuscular electrostimulation

Device: geko plus R-2

Interventions

geko plus R-2 DEVICE

The gekoTM plus R-2 devices (acting on the common peroneal nerve) and IPC devices will be activated for 10mins prior to measuring blood flow. The sequence of application of IPC and gekoTM plus R-2 devices will be randomly selected with 10 minutes recovery between active therapies.

geko plus R-2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Intact healthy skin at the site of device application
• Able to understand the Patient Information Sheet
• Willing and able to give informed consent
• Willing and able to follow the requirements of the protocol
• Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 2 cm2 and less than 10 cm in maximum diameter,
• ABPI of 0.8-1.2 inclusive

You may not qualify if:

• Wound infection either acute or chronic
• History of significant haematological disorders or DVT with the preceding six months
• Pregnant
• Pacemakers or implantable defibrillators
• Use of any other neuro-modulation device
• Current use of TENS in pelvic region, back or legs
• Use of investigational drug or device within the past 4 weeks that may interfere with this study
• Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator.
• Recent trauma to the lower limbs
• Size of leg incompatible with the gekoTM plus R-2 device
• Obesity (BMI \> 34)
• Any medication deemed to be significant by the Investigator
• Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension, or less than 2cm.
• Diabetes
• Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)

Sponsors & Collaborators

• Firstkind Ltd: lead

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share