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Chemical Analysis of Limb Microfluidics

NCT06050499 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2023-09-26

No results posted yet for this study

Summary

Compartment syndrome (CS) is a condition where an increase in pressure in an anatomical compartment (e.g. the lower leg) affects the blood supply of the tissues, leading to tissue damage. The condition is difficult to diagnose, and more difficult to determine when and how to manage it.

Treatment aims to reduce the pressure in the compartment by whatever means possible. Surgical management by of CS is highly invasive and has associated risks including infection, damage to local structures (i.e. nerves), and possibly the inability to close the wound leading to the need for further reconstructive procedures.

The clinical challenge in suspected CS is knowing if and when to intervene. Some cases of mild CS may resolve without an operation, and therefore intervening too soon causes unnecessary harm to the patient. However, waiting too long to operate with high compartmental pressures may lead to irreversible damage to the tissues, resulting in either a useless limb or necrotic tissue needing amputation.

Current strategies for determining limb health include interrogation of symptoms, signs on examination, and serial measurements of compartmental pressures, but no absolute measurement of tissue health. As such, there is an element of clinical judgment in management and no evidence base with which to develop clear treatment guidelines. There is a need for a minimally invasive method of continuously monitoring tissue health to improve the understanding of CS and its management before significant improvement in patient outcomes can be delivered.

It is proposed the application of leg "microfluidics" - analysis of samples of leg fluid - in a series of predictable clinical scenarios which simulate the threatened and unsalvageable limb. This is with an ultimate aim of developing a method of limb fluid sampling that can predict if CS is present and requires intervention.

Conditions

  • Limb Ischemia
  • Compartment Syndrome of Leg

Interventions

DEVICE

Microdialysis catheter + biosensor

Microdialysis catheter from linton instrumetal "63 MD Catheter"

Sponsors & Collaborators

  • The Drummond Foundation (RAMC charity)

    collaborator UNKNOWN

  • Imperial College London

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-12-31
Completion
2024-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06050499 on ClinicalTrials.gov