Transdermal Fluid Removal in Fluid Overload

The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Odema
• Intervention / Treatment: Device: Transdermal Fluid Removal

Detailed Description

Fluid overload is distressing and is particularly prevalent in patients with vital organ dysfunction such as in kidney and heart disease. Due to the patient's inability to remove excess wastes and water, these accumulate in their body fluid compartments. Such excess fluid and toxins have to be removed with high dose diuretics (water tablets or injections) or by frequent dialysis. Treatment with diuretics is effective initially in some patients but is fraught with risks and side effects. The retained fluid and wastes are mainly lodged within the extracellular compartment (interstitial or tissue fluid) and exert deleterious effects on cell functions. Much of this excess fluid collects relatively superficially within the skin, especially in the lower extremities or other dependent body parts as oedema.

The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal.

Principal aim of the research: To investigate whether the TFR device can remove clinically viable or relevant volumes of fluid transdermally in advanced heart failure and other patients with significant oedema. "Clinically viable" volume is defined as the removal of 200ml or more of fluid in a session of up to 10 hours (or 0.43 ml/h per 1cm2 of the skin area treated with microneedles).

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WU
    • Manchester University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants aged >18 years
• Diagnosis of heart failure
• Presence of visible oedema

Exclusion Criteria:

• Inability to give consent
• Patient on warfarin or simthrome (acecoumarol) with International Normalised Ratio (INR) >3 or other bleeding disorders
• Extensive skin disease, infected or broken skin over intended study area
• Pregnancy NB: Patients with pacemakers or implantable cardiac devices (ICD) may be recruited but will not have bioimpedance measurements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Interventional arm; Total and segmental body fluid volumes (total water, extracellular water and interstitial water) will be measured by Segmental Bioelectrical Impedance Spectroscopy (as per manufacturer instructions of use). Areas with most significant oedema and skin in a suitable condition shall be selected for the TFR application. Moisture Meter shall be used at the selected site to measure the skin water content at 4 depths (0.5mm, 1.5mm, 2.5mm and 5mm).

Device: Transdermal Fluid Removal; The Transdermal Fluid Removal (TFR) device is designed for use on the lower limbs of patients with Chronic Heart Failure and treatment resistant peripheral oedema. The TFR device is intended to be applied on oedematous skin of eligible patients, for periods of up to 10 hours at a time, to gently remove excess fluid through the skin, over a period of a few days during exacerbations, thereby avoiding hospitalisation for intravenous diuretics. The TFR device is designed to be used in conjunction with standard Negative Pressure Wound Therapy (NPWT) devices which are currently CE Marked and approved for use in both acute and homecare environment.; Other Names: TFR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Success rate (volume): the % of patients that achieved the removal >200ml of fluid transdermally in a session.	Primary outcome/endpoint	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Success rate (flow rate): % of patients in whom >0.43 ml/h per 1cm2 was removed using either 550µm or 850µm microneedles	% of patients in whom >0.43 ml/h per 1cm2 was removed using either 550µm or 850µm microneedles as reported on CRF	12 months
Success rate with short (550µm) and long (850 µm) microneedles respectively: % of patients in each category in whom >200ml or >0.43 ml/h per 1cm2 was removed	% of patients in each category in whom >200ml or >0.43 ml/h per 1cm2 was removed as reported on CRF	12 months
Microneedle insertion depth/force ratio: Mean (+SD) of microneedle skin insertion depth/insertion force used per microneedle type (550 µm and 850µm)	Mean (+SD) of microneedle skin insertion depth/insertion force used per microneedle type (550 µm and 850µm) as reported on CRF v1.0 and then analysed using appropriate statistics	12 months
Proportion of successfully penetration of microneedles per array: Tertile bands of successfully penetrated microneedle per array	Tertile bands of successfully penetrated microneedle per array	12 months
Incidence (%) of adverse rate per event and for all events	Adverse event rate: Incidence (%) of adverse rate per event and for all events as reported on AE log v4.0	12 months
Tolerability of TFR: N (%) in categories: "Well, very well, poorly or very poorly" tolerated.	N (%) in categories: "Well, very well, poorly or very poorly" tolerated reported on CRF	12 months
Characteristics of patients with successful versus unsuccessful TFR (e.g. demographics, extent of oedema, bioimpedance volumes, serum albumin)	N/mean/median (%/SD/IQR) as appropriate for single and multiple characteristics for "successful" and unsuccessful TFR groups as reported on CRF and then analysed using appropriate statistics.	12 months
Impact of the fluid extraction on routine activities including mobility, comfort, recovery experience: N (%) patients reporting "improved, no change or worsening" of each parameter.	N (%) patients reporting "improved, no change or worsening" of each parameter as reported on CRF, free text narrative and then analysed using appropriate statistics.	12 months
Patient' views on impact, usability and potential of the TFR device: N (%) patients reporting positive, negative or neutral in each category.	N (%) patients reporting positive, negative or neutral in each category, qualitative analysis and then analysed using appropriate statistics.	12 months

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Medical Research Council; British Heart Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2020
• Primary Completion (ACTUAL): March 14, 2022
• Study Completion (ACTUAL): March 14, 2022

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (ACTUAL): May 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: B00097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No