NCT07666828

Brief Summary

The goal of this clinical investigation is to evaluate the performance of three neuromuscular electrical stimulation (NMES) foot pad programmes in healthy adults. It will also learn about how well the NMES programmes are tolerated. The main questions it aims to answer are:

  • Do two newly-developed NMES programmes ('P1' and 'PM7') increase lower limb blood flow more than the existing 'Medic' NMES programme during use?
  • How do the programmes compare in terms of user discomfort and muscle oxygenation during use? Researchers will compare the P1 and PM7 programmes with the existing Medic programme to determine whether the new programmes produce greater improvements in lower limb haemodynamics during device use. Participants will:
  • Attend four study visits at a single research site.
  • Complete 1 familiarisation visit and 3 testing visits, with 12 hours to 7 days between visits.
  • Use all three NMES programmes once in a randomised order.
  • Receive 30 minutes of NMES during each testing visit.
  • Undergo blood flow and muscle oxygenation measurements during each test.
  • Complete questionnaires about discomfort and their experience using the device.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
5mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Sep 2026Mar 2027

First Submitted

Initial submission to the registry

June 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

June 19, 2026

Last Update Submit

September 22, 2026

Conditions

Healthy

Keywords

Neuromuscular Electrical StimulationHealthyBlood flow

Outcome Measures

Primary Outcomes (1)

  • Change in blood volume flow at the superficial femoral artery (SFA)

    Change in blood volume flow from baseline at the superficial femoral artery during a single 30-minute neuromuscular electrical stimulation (NMES) programme. Blood volume flow will be measured using Doppler ultrasound and compared between the Medic, P1, and PM7 NMES programmes.

    Throughout a 10-minute baseline, the 30-minute stimulation session and 8-minute post-stimulation period.

Secondary Outcomes (2)

  • Change in muscle oxygen saturation (SmO2) at the medial gastrocnemius

    Throughout a 10-minute baseline, the 30-minute stimulation session and 8-minute post-stimulation period.

  • Discomfort during NMES stimulation

    During the 30-minute stimulation session

Study Arms (3)

Medic

ACTIVE COMPARATOR

Participants receive the Medic programme delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session.

Device: Medic

P1

EXPERIMENTAL

Participants receive the Programme 1 (P1) delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session.

Device: P1

PM7

EXPERIMENTAL

Participants receive the PM7 programme delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session.

Device: PM7

Interventions

MedicDEVICE

The Medic programme is a currently marketed neuromuscular electrical stimulation (NMES) foot pad programme. It delivers electrical stimulation through the soles of the feet, via a commercially available NMES medical device, to induce lower limb muscle contractions and improve blood circulation during use.

Also known as: Medic programme
Medic
P1DEVICE

Programme 1 (P1) is an investigational NMES foot pad programme that incorporates a modified stimulation pattern designed to reduce muscle adaptation during a 30-minute stimulation session while maintaining the same intended purpose and mode of action as the marketed programme.

Also known as: Programme 1
P1
PM7DEVICE

Personalised Medic v7 (PM7) is an investigational NMES foot pad programme that incorporates a modulation function intended to optimise the haemodynamic response during stimulation while maintaining the same intended purpose and mode of action as the marketed programme.

Also known as: Personalised Medic Programme v7
PM7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Age 18 or over
  • Ability to communicate in English and provide informed consent

You may not qualify if:

  • Lack of capacity to provide informed consent
  • Electronic implanted device (e.g. cardiac pacemaker)
  • Pregnancy or intending to become pregnant during the study period
  • Currently being treated for or have symptoms of an existing deep vein thrombosis (DVT)
  • Diagnosis of vascular disease or disorder
  • Terminal illness
  • Neurological disorders (e.g. epilepsy)
  • Musculoskeletal injury/disorders (e.g. recent injury or surgery)
  • Skin conditions (e.g. eczema or open wounds near plantar surface of the foot)
  • Cardiovascular conditions (e.g. arrhythmia or uncontrolled hypertension)
  • Diabetes mellitus with neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Lightbox

Bracknell, Berkshire, RG12 8FB, United Kingdom

RECRUITING

Related Publications (2)

  • Kumaran B, Targett D, Watson T. Benefits of home-based foot neuromuscular electrical stimulation on self-reported function, leg pain and other leg symptoms among community-dwelling older adults: a sham-controlled randomised clinical trial. BMC Geriatr. 2024 Aug 14;24(1):683. doi: 10.1186/s12877-024-05271-z.

    PMID: 39143586BACKGROUND

  • Varatharajan L, Williams K, Moore H, Davies AH. The effect of footplate neuromuscular electrical stimulation on venous and arterial haemodynamics. Phlebology. 2015 Oct;30(9):648-50. doi: 10.1177/0268355514542682. Epub 2014 Jul 4.

    PMID: 24997200BACKGROUND

Study Officials

  • Joey O Porter

    Actegy Ltd.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joey O Porter, MSc

CONTACT

+44 7415605740joseph.porter@actegy.com

Zoe Steele

CONTACT

+44 1344636940zoe.steele@actegy.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 24, 2026

Study Start

September 22, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because this is an early feasibility, manufacturer-sponsored exploratory investigation with a small sample size (n=24). Due to the limited study population and the potential risk of participant re-identification, de-identified participant-level datasets will not be made publicly available. Aggregate study results will be reported through ClinicalTrials.gov and any resulting scientific publications.

Locations

GB(1)