Limb IschemiaCALMNCT06050499
Chemical Analysis of Limb Microfluidics
An observational study of Limb Ischemia and Compartment Syndrome of Leg, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limb Ischemia, Compartment Syndrome of Leg
- What is being tested?
- Microdialysis catheter + biosensor
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2023to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adult patients (aged greater than or equal to 18 years) who are either:
- 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).
- At risk of developing compartment syndrome following trauma or surgical intervention as determined by the clinical care team.
Who cannot join
- Age <18 years old Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London, W21NY
Madelaine Gimzewska, MBChB, +442075948904, m.gimzewska@imperial.ac.uk
Richard Kwasnicki, MBChB PhD
About this study
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.
Read more
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
- Being tested
- Microdialysis catheter + biosensor
- Keywords
- Microfluidics, Compartment syndrome, Limb ischaemia
- Medical subject headings
- Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdialysis catheter + biosensorDevice
Microdialysis catheter from linton instrumetal "63 MD Catheter"
| Study group | Role | What they receive |
|---|---|---|
| Irreversible ischaemia | patients undergoing elective amputation of a limb (e.g. peripheral vascular disease) Receives: Device: Microdialysis catheter + biosensor | |
| Reversible ischaemia | patients undergoing an operation with a limb tourniquet or intentional controlled reduction in blood flow to the lower limb (e.g. aortic cross clamping for vascular surgery). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative concentrations of key metabolites
Relative concentrations of key metabolites (glucose, potassium, lactate) in lower limb interstitial fluid, estimated against baseline
Measured: 20 minutes (real time analysis that takes 20 minutes to register from point of sampling to result)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Feb 2023
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- The Drummond Foundation (RAMC charity)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050499
- Sponsor's protocol ID
- 20SM5770
- Other IDs
- IRAS
- Acronym
- CALM
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemical Analysis of Limb Microfluidics
- ClinicalTrials.gov ID
- NCT06050499
- Acronym / sponsor ID
- CALM / 20SM5770
- Conditions
- Limb Ischemia, Compartment Syndrome of Leg
- Keywords
- Microfluidics, Compartment syndrome, Limb ischaemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- The Drummond Foundation (RAMC charity)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irreversible ischaemia | – | Device: Microdialysis catheter + biosensorpatients undergoing elective amputation of a limb (e.g. peripheral vascular disease) |
| Reversible ischaemia | – | –patients undergoing an operation with a limb tourniquet or intentional controlled reduction in blood flow to the lower limb (e.g. aortic cross clamping for vascular surgery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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).
- At risk of developing compartment syndrome following trauma or surgical intervention as determined by the clinical care team.
Key exclusion criteria (1 listed)
- Age <18 years old Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microdialysis catheter + biosensorMicrodialysis catheter from linton instrumetal "63 MD Catheter" | Device | Irreversible ischaemia |
Primary outcome
Relative concentrations of key metabolites
Time frame: 20 minutes (real time analysis that takes 20 minutes to register from point of sampling to result)
Relative concentrations of key metabolites (glucose, potassium, lactate) in lower limb interstitial fluid, estimated against baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Ischemia and Compartment Syndrome of Leg, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative concentrations of key metabolites (time frame: 20 minutes (real time analysis that takes 20 minutes to register from point of sampling to result)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.