Acute Compartment SyndromeSoftpHNCT04725604
Real-time Soft Tissue Assessment Using a Technologically Advanced pH Monitoring System
A study testing pH probe in people with Acute Compartment Syndrome, run by University of Aberdeen at 7 sites in United Kingdom.
Trial summary
Acute Compartment Syndrome (ACS) can occur when there is a gradual reduction in the blood supply to injured limbs, most commonly after fractures or crush injuries. If ACS is not diagnosed early enough, it can result in muscle and other tissues dying off because of the lack of blood supply. Read more about this study
- Who is it for?
- Ages 16 to 59 years
- Conditions the study is for
- Acute Compartment Syndrome
- What is being tested?
- pH probe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 1 Mar 2024to 28 Jul 2025
- Phase
- Interventional
- 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 16 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Orthopaedic Limb injuries that are at increased risk of developing ACS. In particular the following injuries will have been sustained to permit inclusion:
- Tibial diaphyseal fractures
- High energy injuries around the knee (such as dislocations of the knee, fracture dislocations of the knee or complex fractures involving the proximal tibia e.g. Shatzker IV - VI types).
- Forearm diaphyseal fractures
- High energy injuries around the elbow resulting in complex fracture dislocations.
- Significant crush injuries to the lower or upper limbs, including thigh, lower leg, upper arm and forearm, where compartment syndrome is suspected, in the presence or absence of a fracture.
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- Male and female participants will be a minimum of sixteen years of age and under 60 years of age.
- Participants should be able to understand spoken and written English.
- Able and willing to give verbal agreement or informed consent to participate.
Who cannot join
- Patients who have evidence of previous ACS in the affected limb are not eligible.
- Patients who were, prior to injury, receiving anticoagulant therapy (with the exception of aspirin or other anti-platelet aggregation drugs) for pre-existing conditions should also be excluded from the study.
- Patients who have other illnesses/disease processes for whom the study could be detrimental will be excluded from the study (for example those with blood clotting disorders, current leukaemia, currently chemotherapy treatment, visible signs of peripheral vascular disease).
- Eligible patients will have recently sustained a serious injury - in these circumstances, pregnancy testing is challenging and not routinely done in clinical practice. We will exclude patients who declare that they are pregnant.
Trial locations and contacts
7 sites in 1 country.
Seonaidh Cotton contact
7 sites in 1 country
United Kingdom7 sites
NHS Grampian
Aberdeen, Aberdeen City, AB15 6RE
Iain Stevenson, iainstevenson77@gmail.com
Iain Stevenson
University Hospital Birmingham
Birmingham, B15 2TH
Ansar Mahmood, ansar.mahmood@uhb.nhs.uk
Ansar Mahmood
NHS Tayside
Dundee, DD3 8EA
Fraser Harrold, fraserharrold@doctors.org.uk
Fraser Harrold
NHS Lothian
Edinburgh, EH1 3EG
Tim White, timwhite@doctors.org.uk
Tim White
NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary
Glasgow, G12 0XH
Angus MacLean, admaclean@hotmail.com
NHS Greater Galsgow and Clyde - Queen Elizabeth University Hospital
Glasgow, G51 4TF
Bilal Jamal, bjamal@doctors.org.uk
NHS Greater Glasgow and Clyde - Royal Alexandra Hospital
Glasgow, PA2 9PJ
Jibu Joseph, Jibu.joseph@ggc.scot.nhs.uk
About this study
Official title: Real-time Soft Tissue Assessment Using a Technologically Advanced pH
Acute Compartment Syndrome (ACS) can occur when there is a gradual reduction in the blood supply to injured limbs, most commonly after fractures or crush injuries. If ACS is not diagnosed early enough, it can result in muscle and other tissues dying off because of the lack of blood supply. Diagnosing ACS remains a challenge for doctors - currently clinical assessment and pressure probes are used to assess patients at risk of ACS. Previous research has shown that measuring pH in injured muscles is promising in diagnosing ACS and may help doctors diagnose ACS earlier than they can using current methods.
In this study, the investigators will use a pH probe to measure muscle pH, and in particular, any build-up of acid caused by reduced blood flow in the injured limb. The investigators will compare the pH probe values with the existing methods for diagnosing ACS.
Read more
Patients with a fracture or crush injury who are risk of developing ACS will be recruited into the study. Participants will have a pH probe inserted into tissue close to their injury and pH data will be logged for up to 72 hours. Diagnosis and any treatment decisions for participants in the study will be made using the existing methods and not based on information from the pH probe (the team treating the patient will not have access to the pH data). Data on diagnosis and any treatment given for ACS will be collected from participant's medical notes. The Soft pH trial team will compare how well the pH probe performs in diagnosing ACS compared to the existing methods. The investigators will follow participants up at 6 months after their initial injury to identify missed ACS cases based on clinical findings.
Diagnosing ACS earlier may reduce the likelihood of long-term symptoms and loss of function that is often seen in cases of ACS.
Read the detailed description
Patients who are admitted to an orthopaedic trauma unit or intensive care unit with fractures or crush injuries and who are at risk of developing Acute Compartment Syndrome (ACS) are eligible for the study.
These patients will undergo routine monitoring for signs and symptoms of ACS. Patients who are able to make decisions about the ongoing treatment of their injured limb will be approached about the study. The patient will initially be given a short verbal statement about the study. At this point, patients may agree to take part or request additional information about the study. If patients request additional information, they can be offered a brief Patient Information Leaflet (PIL) or more detailed PIL. After reading this, they may agree to take part. Patients who agree to take part can either give verbal agreement to take part at this stage, or written informed consent.
Patients who agree to take part will have a pH probe inserted into their injured limb. The pH probe will be attached to a pH monitor which will record pH data for up to a maximum of 72 hours (24 hours per probe). The surgical team will not have access to the pH data. During the time participants are considered "at risk" for ACS, patients will be monitored in the routine way (using regular clinical assessment and pressure monitoring). If ACS is diagnosed in the routine way, then treatment (fasciotomy) will be offered as appropriate.
Once patients start to recover, written informed consent will be sought from those participants who gave verbal agreement at the outset of their participation in the study.
Until their discharge from hospital, clinical information will be collected from their medical notes or collected directly onto the study case report forms. Information from the pH monitor will be downloaded into the study website.
Participants will usually be followed up as part of routine care approximately 6 months after their initial injury. Where possible, the study follow-up will coincide with this routine follow-up. The study follow-up will include clinical examination of the limb that sustained the initial injury (including any evidence of contracture, strength of flexion/extension and any sensory abnormalities). At the 6 month follow-up participants will also be asked to complete a quality of life questionnaire.
The primary objective is to establish that the Softcell pH monitoring system measures muscle pH in an injured limb over time, monitoring changes in muscle pH that are consistent with ischaemia (drops in pH).
The properties of the pH probe as a diagnositic test will be investigated. The first analysis will be carried out after recruitment is complete, and initial data (up to 72 hours monitoring for ACS, and to potential discharge) is available. For this analysis, the presence of disease will be defined as fasciotomy within 72 hours.
A second analysis will be undertaken at the end of the study after the 6 month patient reviews have been undertaken. For this analysis, the presence of disease will be defined as fasciotomy within 72 hours OR evidence of contracture at 6 months OR significant reduction in strength OR significant sensory loss which is not improving by six months that anatomically suggest ACS.
- Conditions
- Acute Compartment Syndrome
- Being tested
- pH probe
- Keywords
- Acute Compartment Syndrome, Fasciotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pH probeDevice
Patients who agree to take part will have a pH probe inserted into their injured limb. The pH probe will be attached to a pH monitor which will record pH data for up to a maximum of 72 hours (24 hours per probe). The surgical team will not have access to the pH data. During the time they are considered "at risk" for ACS, patients will be monitored in the routine way (using regular clinical assessment and pressure monitoring). If ACS is diagnosed in the routine way, then treatment (fasciotomy) will be offered as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| pH Probe | Experimental | Softcell pH monitoring system: designed to measure intramuscular pH levels in patients with fracture or crush injuries sufficiently severe to be at risk of developing ACS. Receives: Device: pH probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-muscular pH
ph measured by Softcell device
Measured: up to 72 hours
Secondary outcomes (7)
Intra-compartmental pressure
pressure as measured by standard clinical equipment
Measured: up to 72 hours
No of people with Acute Compartment Syndrome
Standard clinical assessment for Acute Compartment Syndrome up to 72 hours
Measured: Up to 72 hours
No of people with Acute Compartment Syndrome
Standard clinical assessment for Acute Compartment Syndrome at 6 months
Measured: At 6 months
Generic Quality of Life
EQ-5D-5L Scored -10 -100. (-10 being the worst health you can imagine and 100 being the best health you can imagine
Measured: 6 months
Disease specific Quality of Life - Upper limb
Disabilities of the Arm, Shoulder and Hand - Scored from 0 - 100 (0 = no disability , 100 = severely disabled)
Measured: 6 months
Disease specific Quality of Life - Lower limb
Short Musculoskeletal Function Assessment - Scored from 0 - 100 (o = no disability, 100 = severely disabled).
Measured: 6 months
Number of participants with adverse events
Standard clinical assessment for adverse events
Measured: Up to 144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Mar 2024 (estimated)
- Primary completion28 Jul 2025 (estimated)
- Study completion28 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Compartment SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Blinded diagnostic field study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian, Softcell Medical Ltd
- Responsible party
- Sponsor
- Investigators
- Iain Stevenson, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725604
- Sponsor's protocol ID
- 3-061-18
- Other IDs
- 21-NS-0005
- Acronym
- SoftpH
- Status last verified
- Dec 2023
- First submitted
- 16 Dec 2020
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Soft Tissue Assessment Using a Technologically Advanced pH
- ClinicalTrials.gov ID
- NCT04725604
- Acronym / sponsor ID
- SoftpH / 3-061-18
- Conditions
- Acute Compartment Syndrome
- Keywords
- Acute Compartment Syndrome, Fasciotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian, Softcell Medical Ltd
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 28 Jul 2025 (estimated)
- Study completion
- 28 Jul 2025 (estimated)
- First posted
- 27 Jan 2021 (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.
Acute Compartment Syndrome (ACS) can occur when there is a gradual reduction in the blood supply to injured limbs, most commonly after fractures or crush injuries. If ACS is not diagnosed early enough, it can result in muscle and other tissues dying off because of the lack of blood supply. Diagnosing ACS remains a challenge for doctors - currently clinical assessment and pressure probes are used to assess patients at risk of ACS. Previous research has shown that measuring pH in injured muscles is promising in diagnosing ACS and may help doctors diagnose ACS earlier than they can using current methods.
In this study, the investigators will use a pH probe to measure muscle pH, and in particular, any build-up of acid caused by reduced blood flow in the injured limb. The investigators will compare the pH probe values with the existing methods for diagnosing ACS.
Patients with a fracture or crush injury who are risk of developing ACS will be recruited into the study. Participants will have a pH probe inserted into tissue close to their injury and pH data will be logged for up to 72 hours. Diagnosis and any treatment decisions for participants in the study will be made using the existing methods and not based on information from the pH probe (the team treating the patient will not have access to the pH data). Data on diagnosis and any treatment given for ACS will be collected from participant's medical notes. The Soft pH trial team will compare how well the pH probe performs in diagnosing ACS compared to the existing methods. The investigators will follow participants up at 6 months after their initial injury to identify missed ACS cases based on clinical findings.
Diagnosing ACS earlier may reduce the likelihood of long-term symptoms and loss of function that is often seen in cases of ACS.
Detailed description
Patients who are admitted to an orthopaedic trauma unit or intensive care unit with fractures or crush injuries and who are at risk of developing Acute Compartment Syndrome (ACS) are eligible for the study.
These patients will undergo routine monitoring for signs and symptoms of ACS. Patients who are able to make decisions about the ongoing treatment of their injured limb will be approached about the study. The patient will initially be given a short verbal statement about the study. At this point, patients may agree to take part or request additional information about the study. If patients request additional information, they can be offered a brief Patient Information Leaflet (PIL) or more detailed PIL. After reading this, they may agree to take part. Patients who agree to take part can either give verbal agreement to take part at this stage, or written informed consent.
Patients who agree to take part will have a pH probe inserted into their injured limb. The pH probe will be attached to a pH monitor which will record pH data for up to a maximum of 72 hours (24 hours per probe). The surgical team will not have access to the pH data. During the time participants are considered "at risk" for ACS, patients will be monitored in the routine way (using regular clinical assessment and pressure monitoring). If ACS is diagnosed in the routine way, then treatment (fasciotomy) will be offered as appropriate.
Once patients start to recover, written informed consent will be sought from those participants who gave verbal agreement at the outset of their participation in the study.
Until their discharge from hospital, clinical information will be collected from their medical notes or collected directly onto the study case report forms. Information from the pH monitor will be downloaded into the study website.
Participants will usually be followed up as part of routine care approximately 6 months after their initial injury. Where possible, the study follow-up will coincide with this routine follow-up. The study follow-up will include clinical examination of the limb that sustained the initial injury (including any evidence of contracture, strength of flexion/extension and any sensory abnormalities). At the 6 month follow-up participants will also be asked to complete a quality of life questionnaire.
The primary objective is to establish that the Softcell pH monitoring system measures muscle pH in an injured limb over time, monitoring changes in muscle pH that are consistent with ischaemia (drops in pH).
The properties of the pH probe as a diagnositic test will be investigated. The first analysis will be carried out after recruitment is complete, and initial data (up to 72 hours monitoring for ACS, and to potential discharge) is available. For this analysis, the presence of disease will be defined as fasciotomy within 72 hours.
A second analysis will be undertaken at the end of the study after the 6 month patient reviews have been undertaken. For this analysis, the presence of disease will be defined as fasciotomy within 72 hours OR evidence of contracture at 6 months OR significant reduction in strength OR significant sensory loss which is not improving by six months that anatomically suggest ACS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Blinded diagnostic field study
| Arm | Type | Receives |
|---|---|---|
| pH Probe | Experimental | Device: pH probeSoftcell pH monitoring system: designed to measure intramuscular pH levels in patients with fracture or crush injuries sufficiently severe to be at risk of developing ACS. |
Who may qualify
- Ages
- 16 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Orthopaedic Limb injuries that are at increased risk of developing ACS. In particular the following injuries will have been sustained to permit inclusion:
- Male and female participants will be a minimum of sixteen years of age and under 60 years of age.
- Participants should be able to understand spoken and written English.
- Able and willing to give verbal agreement or informed consent to participate.
Key exclusion criteria (4 listed)
- Patients who have evidence of previous ACS in the affected limb are not eligible.
- Patients who were, prior to injury, receiving anticoagulant therapy (with the exception of aspirin or other anti-platelet aggregation drugs) for pre-existing conditions should also be excluded from the study.
- Patients who have other illnesses/disease processes for whom the study could be detrimental will be excluded from the study (for example those with blood clotting disorders, current leukaemia, currently chemotherapy treatment, visible signs of peripheral vascular disease).
- Eligible patients will have recently sustained a serious injury - in these circumstances, pregnancy testing is challenging and not routinely done in clinical practice. We will exclude patients who declare that they are pregnant.
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 |
|---|---|---|
| pH probePatients who agree to take part will have a pH probe inserted into their injured limb. The pH probe will be attached to a pH monitor which will record pH data for up to a maximum of 72 hours (24 hours per probe). The surgical team will not have access to the pH data. During the time they are considered "at risk" for ACS, patients will be monitored in the routine way (using regular clinical assessment and pressure monitoring). If ACS is diagnosed in the routine way, then treatment (fasciotomy) will be offered as appropriate. | Device | pH Probe |
Primary outcome
Intra-muscular pH
Time frame: up to 72 hours
ph measured by Softcell device
7 secondary outcomes
Intra-compartmental pressure
Time frame: up to 72 hours
No of people with Acute Compartment Syndrome
Time frame: Up to 72 hours
No of people with Acute Compartment Syndrome
Time frame: At 6 months
Generic Quality of Life
Time frame: 6 months
Disease specific Quality of Life - Upper limb
Time frame: 6 months
Disease specific Quality of Life - Lower limb
Time frame: 6 months
Number of participants with adverse events
Time frame: Up to 144 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
Seonaidh Cotton contact
Iain Stevenson principal investigator
NHS Grampian
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pH probe in people with Acute Compartment Syndrome, run by University of Aberdeen at 7 sites 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 9 inclusion and 4 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Contact Karen Innes (01224438089, softph@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-muscular pH (time frame: up to 72 hours). 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 19 Dec 2023.