Chemical Analysis of Limb Microfluidics

Limb Ischemia Clinical Trial

— CALM  

Official title:

Chemical Analysis of Limb Microfluidics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050499
• Other study ID #: 20SM5770
• Secondary ID: IRAS
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult patients (aged greater than or equal to 18 years) who are either:

i. Undergoing an intervention where there is a controlled reduction in blood flow to the limb that is reversible (e.g. using a tourniquet or clamp) or irreversible (e.g. during limb amputation).

ii. At risk of developing compartment syndrome following trauma or surgical intervention as determined by the clinical care team.

Exclusion Criteria:

Age <18 years old Unable to provide informed consent

Related Conditions & MeSH terms

• Compartment Syndrome of Leg
• Compartment Syndromes
• Ischemia
• Limb Ischemia

Intervention

Device:
• Microdialysis catheter + biosensor
Microdialysis catheter from linton instrumetal "63 MD Catheter"

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	The Drummond Foundation (RAMC charity)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative concentrations of key metabolites	Relative concentrations of key metabolites (glucose, potassium, lactate) in lower limb interstitial fluid, estimated against baseline	20 minutes (real time analysis that takes 20 minutes to register from point of sampling to result)