A pilot study to observe the use of a portable Pneumatic compression pump as part of self-management in swollen legs

A pilot evaluation on the safety and efficacy of the Haddenham Lymphflow Go pneumatic compression device in patients with lymphoedema and chronic venous insufficiency as part of self management.

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13816594

Enrollment

Registered

2025-06-06

Start date

2025-06-02

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoedema and chronic venous insufficiency Circulatory System

Interventions

Day 1- Initial Appointment During the initial appointment (Day 1) participant will be asked to expose their legs for a series of measurements/procedures. These measurements/procedures will consist of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of Primary/Secondary Lymphoedema, Oedema following trauma and/or sports injuries, Post Immobilization Oedema, Venous Insufficiency, Treatment and Assistance in Healing Stasis Dermatitis, Venous, Stasis Ulcers or Arterial and Diabetic Ulcers, Phlebolymphoedema. 2. Have capacity to provide informed consent and follow instructions for using the device as stated in the instructions for use (IFU). 3. Have good mobility which allows to lift legs when sitting and safely position on a treatment couch. 4. BMI less than 32 kg/m².

Exclusion criteria

Exclusion criteria: 1. Aged under 18 years old. 2. Do not have capacity to provide informed consent or follow the instructions in the IFU. 3. Have limited mobility which means participants are unable to lift their legs or safely position themselves on a treatment couch. 4. BMI over 32 kg/m². 5. History or active cardiovascular diseases: Heart Failure, Acute Venous Disease, Severe Peripheral Artery Disease 6. Active Skin or Limb Infection/Inflammatory Disease 7. Any circumstance where increased lymphatic or venous return is undesirable. 8. Pregnancy

Design outcomes

Primary

Measure	Time frame
1. Limb Volume measurements taken using a tape measure and inputted into LIMBSTAT at baseline and day 14 2. Percentage water content taken using the Delfin® Lymph Scanner® at set points throughout the limb taken at baseline and day 14	—

Secondary

Measure	Time frame
1. Quality of life questionnaire using LYMQOL taken at baseline and day 14 2. Feedback questionnaire to be completed at the end of the study on day 14	—

Countries

England, United Kingdom

Contacts

Public ContactNatalie Dawn Phillips

natalie@lymphatic.co.uk+44 7359151323

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026