Dupuytren&Amp;#39;s ContracturePRESCETNCT07024576
Preoperative Serial Casting, Education, and Therapy for Dupuytren's Contracture
A study testing Preoperative casting intervention in people with Dupuytren&Amp;#39;s Contracture and Dupuytren&Amp;#39;s Fasciectomy, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
We are running a small study to test whether a special type of therapy - including casting, stretching, and massage - might help improve recovery after Dupuytren's Fasciectomy. The study is taking place at Dorset County Hospital and will involve people who are already scheduled for surgery and have a permanent bend of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren&Amp;#39;s Contracture, Dupuytren&Amp;#39;s Fasciectomy, Dupuytren&Amp;#39;s Disease
- What is being tested?
- Preoperative casting intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Male or female participants aged 18 years or older.
- One or more fingers with a Dupuytren's flexion contracture greater than 30° at the PIP joint.
- Awaiting fasciectomy surgery for Dupuytren's contracture.
- Willing and able to provide informed consent for participation in the study.
Who cannot join
- Individuals awaiting needle fasciotomy, dermofasciectomy, or segmental fasciectomy.
- A history of previous treatment for Dupuytren's contracture (e.g., surgery, collagenase injection, or needle fasciectomy) to the study reference digit.
- A history of any other pre-existing hand disorder causing significant movement restriction, pain, or affecting hand function (e.g., post-traumatic stiffness, arthritis, infection).
- Non-English speaking participants due to the need for completing multiple questionnaires that have not been validated in multiple languages.
- Inability to attend follow-up appointments within the required timeframes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carol Clark contact
United Kingdom1 site
Dorchester County Hospital NHS Foundation Trust
Dorchester, Dorset, DT1 2JY
Tahra Babiker-Moore, +44 7974709699, tahrababikermoore@gmail.com
Timothy Crook, timothy.crook@dchft.nhs.uk
About this study
Official title: Preoperative Serial Casting, Stretching, and Massage Therapy Package for Dupuytren's Patients With Severe Proximal Interphalangeal Joint Contracture: A Feasibility Study Protocol for a Randomised Trial
We are running a small study to test whether a special type of therapy - including casting, stretching, and massage - might help improve recovery after Dupuytren's Fasciectomy.
The study is taking place at Dorset County Hospital and will involve people who are already scheduled for surgery and have a permanent bend of 30 degrees or more in the middle joint of one or more fingers.
Read more
The therapy will be given before surgery to see if it helps people get a better result afterwards.
We want to find out:
- Who would be suitable to take part in a future, larger study
- Which results are most important to measure (like finger movement or grip strength)
- How many people complete the full therapy and follow-up We'll also speak to patients and healthcare professionals to understand how acceptable and practical this therapy is.
The goal is to see whether it's possible and worthwhile to run a larger study in the future, to find out if pre-surgery therapy can become a helpful part of treatment for people undergoing Dupuytren's Fasciectomy.
Read the detailed description
Dupuytren's disease is a common and progressively disabling condition affecting the connective tissue of the palm of the hand. It causes fibrosis of the palmar fascia, which can lead to one or more fingers becoming incapable of full extension, adopting a fixed flexion contracture. This loss of extension can significantly impair hand function and limit daily activities. While surgery (typically fasciectomy) remains the most effective treatment for Dupuytren's contracture, outcomes are often less favourable when the deformity involves the proximal interphalangeal joint, particularly in severe cases where the contracture exceeds 30 degrees.
This feasibility study investigates whether a short course of preoperative therapy, delivered before surgery, can help improve recovery and outcomes after Dupuytren's Fasciectomy. The intervention includes:
- Heat application
- Stretching and massage
- Serial casting - a method of gently lengthening tight tissue by applying and adjusting a soft cast weekly prior to surgery The treatment is designed to gently lengthen tight tissues and increase joint range of movement in the affected fingers prior to surgery, with the goal of improving movement and function after surgery.
We are recruiting approximately 20 adult patients from Dorset County Hospital NHS Foundation Trust who:
- Are scheduled for Dupuytren's Fasciectomy
- Have a PIP joint contracture of 30 degrees or more
Participants will be randomly assigned to one of two groups:
- Intervention group: Will receive the four-week preoperative therapy programme plus an education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones.
- Control group: Will receive the same education programme only, with no added preoperative therapy.
After surgery, all participants will follow standard postoperative therapy and attend follow-up appointments up to 12 weeks post-op, where we will collect outcome measures including:
- Finger range of motion
- Hand function (using the Michigan Hand Outcomes Questionnaire - MHQ)
- Grip strength
- Patient satisfaction
- Completion and retention rates throughout the study To understand how practical and acceptable this approach is in real-world clinical settings, we will also conduct interviews with patients and healthcare professionals to explore their experiences and suggestions for improvement.
As a feasibility study, the goal is not to test effectiveness, but to assess whether a larger, definitive trial is achievable. Specifically, we aim to:
- Determine who is suitable and willing to take part
- Identify the most relevant outcome measures
- Evaluate participation and follow-up rates
- Understand acceptability from both patients and clinicians
- Estimate the resources and planning needed for a full-scale trial If this study shows that the intervention is feasible and well-received, we aim to proceed with a multi-centre randomised controlled trial to evaluate the effectiveness of preoperative therapy as part of standard care for Dupuytren's fasciectomy.
This research is a collaboration between Dorset County Hospital NHS Foundation Trust and Bournemouth University, with active involvement and guidance from a Patient and Public Involvement steering group made up of individuals with lived experience of Dupuytren's disease and the healthcare professionals involved in their care.
- Conditions
- Dupuytren&Amp;#39;s Contracture, Dupuytren&Amp;#39;s Fasciectomy, Dupuytren&Amp;#39;s Disease
- Being tested
- Preoperative casting intervention
- Keywords
- Dupuytren's, Fasciectomy, Preoperative therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative casting interventionOther
A serial casting intervention protocol involving the application of heat, stretching, and massage before casting. This is repeated weekly for four weeks, with the cast removed and reapplied each time to promote gradual elongation of restricted tissue.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A serial casting intervention protocol involving the application of heat, stretching, and massage before casting. This is repeated weekly for four weeks, with the cast removed and reapplied each time to promote gradual elongation of restricted tissue. Additionally, they will receive an education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones. Receives: Other: Preoperative casting intervention |
| Control group | No intervention | An education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones only, with no added preoperative therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression criteria assessment
Primary Outcome Measure:
Feasibility of progressing to a full randomised controlled trial (RCT) based on predefined progression criteria across eight domains. These include participant availability (≥37 listed for fasciectomy over 9 months), eligibility rate (≥54%), consent rate among eligible participants (≥80%), and willingness to undergo randomisation (≥80%). Additional feasibility indicators include the ability to maintain blinding of assessors and surgeons throughout the study, high intervention acceptability determined via qualitative evaluation, adherence to preoperative splinting (>80%), and retention at 12-week follow-up (>80%). Safety is assessed by tracking adverse events, with progression supported if ≤20% of participants experience an adverse reaction. Thresholds for "Go," "Amend," or "Stop" decisions are defined for each domain.
Measured: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Secondary outcomes (7)
Active range of movement of the affected finger(s)
Active range of movement of the affected finger(s), recorded individually at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints. Measurements are obtained using a standard manual goniometer, with the participant seated, forearm supported in neutral rotation, and wrist in a neutral position.
- Flexion is defined as the angle at each joint when the participant actively attempts to flex the finger (i.e., make a fist), measured from the neutral (0°) position toward full flexion.
- Extension is defined as the angle achieved at each joint when the participant actively attempts to fully straighten the finger, measured from the neutral position toward full extension or hyperextension.
Each joint is measured and recorded separately in degrees for both maximal flexion and maximal extension. AROM is assessed at baseline, at each preoperative visit, and at 12 weeks postoperatively.
Measured: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Passive range of movement (PROM) of the affected finger(s)
Passive range of movement (PROM) of the affected finger(s), recorded individually at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints. Measurements are obtained using a standard manual goniometer, with the participant seated, forearm supported in neutral rotation, and wrist in a neutral position.
- Passive flexion is defined as the angle at each joint achieved when the examiner passively moves the finger into maximal flexion without patient effort, measured from the neutral (0°) position.
- Passive extension is defined as the angle at each joint when the examiner passively moves the finger into full extension or hyperextension, again without patient effort.
Each joint is measured and recorded separately in degrees for both maximal passive flexion and maximal passive extension. PROM is assessed at baseline, at each preoperative visit, and at 12 weeks postoperatively.
Measured: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Grip strength of the affected hand
Grip strength of the affected hand is measured using a Jamar hydraulic hand dynamometer. Strength is assessed in kilograms (kg) with the participant seated, shoulder adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral position, and wrist positioned between 0-30° extension and 0-15° ulnar deviation.
Participants are instructed to squeeze the dynamometer maximally for 3 seconds. Three trials are performed with a 30-second rest between attempts, and the mean value of the three trials is recorded. The second handle position on the Jamar dynamometer is used for consistency.
Grip strength is measured at baseline, at each preoperative visit, and at 12 weeks postoperatively. Measurements at baseline and 12 weeks postoperatively are performed by therapists blinded to group allocation, using standardised equipment and procedures to ensure reliability and comparability across time points.
Measured: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Michigan Hand Questionnaire (MHQ)
Hand function is assessed using the Michigan Hand Questionnaire (MHQ), a validated, condition-specific, patient-reported outcome measure. The MHQ evaluates six domains: hand function, activities of daily living (ADLs), pain, work performance, aesthetics, and satisfaction with hand function. It consists of 37 items, each domain scored on a 0 to 100 scale. For all domains except pain, higher scores indicate better outcomes; in the pain domain, higher scores reflect greater pain.
Participants complete the MHQ at baseline, at each preoperative visit, and at 12 weeks postoperatively. The questionnaire is administered by a therapist, who reads each question aloud and records the participant's responses directly onto the form, following the standardised MHQ scoring protocol.
Measured: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Patient-Specific Functional Scale (PSFS)
Hand function is also assessed using the Patient-Specific Functional Scale (PSFS). The PSFS is a validated, patient-reported outcome measure used to evaluate functional limitations specific to the individual's condition. Participants are asked to identify up to three activities that they are currently unable to perform or perform with difficulty due to their hand condition.
Each activity is rated on a 0 to 10 numeric rating scale, where 0 represents "unable to perform the activity" and 10 represents "able to perform the activity without any difficulty." Scores are recorded for each activity, and an average score is calculated to reflect overall functional ability.
The PSFS is administered at baseline, at each preoperative visit, and at 12 weeks postoperatively. This outcome measure captures patient-defined functional goals and changes over time, providing a highly individualised and responsive assessment of functional improvement
Measured: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Barriers and facilitators to adherence
Barriers and facilitators to attainment of the intervention, identified through semi-structured qualitative interviews with both participants and healthcare professionals involved in the trial. Interviews are conducted to explore individual and system-level factors that influence engagement with and delivery of the intervention, including adherence, acceptability, perceived benefit, and contextual constraints.
Interviews are conducted at the end of the intervention period with a selection of participants using a topic guide developed from existing literature and trial objectives, and are audio-recorded, transcribed verbatim, and anonymised. Data are analysed thematically using framework analysis to identify recurring themes related to barriers and facilitators to intervention delivery and uptake.
Measured: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Sample size estimation
The sample size estimation for a future definitive trial will be informed by the distribution and completeness of outcome data, and by recruitment, consent, adherence, and retention rates observed during the trial. These estimates will be used to model various trial design scenarios, ensuring adequate power to detect clinically meaningful differences in a future randomised controlled trial.
Measured: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dupuytren&Amp;#39;s ContractureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomised feasibility study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Dorset County Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Timothy Crook, Principal investigator, Dorchester County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024576
- Sponsor's protocol ID
- 11151
- Acronym
- PRESCET
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The findings of the trial will be made publicly available through publication or other dissemination tools without any unnecessary delay. Datasets will be made available by the corresponding author on reasonable request and in accordance with consent and ethical approval.
Publications
Mellor K, Albury C, Dutton SJ, Eldridge S, Hopewell S. Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting. Pilot Feasibility Stud. 2023 Apr 15;9(1):59. doi: 10.1186/s40814-023-01291-5.
PubMed 37061720
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Serial Casting, Stretching, and Massage Therapy Package for Dupuytren's Patients With Severe Proximal Interphalangeal Joint Contracture: A Feasibility Study Protocol for a Randomised Trial
- ClinicalTrials.gov ID
- NCT07024576
- Acronym / sponsor ID
- PRESCET / 11151
- Conditions
- Dupuytren&Amp;#39;s Contracture, Dupuytren&Amp;#39;s Fasciectomy, Dupuytren&Amp;#39;s Disease
- Keywords
- Dupuytren's, Fasciectomy, Preoperative therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Dorset County Hospital NHS Foundation Trust
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Jun 2025 (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.
We are running a small study to test whether a special type of therapy - including casting, stretching, and massage - might help improve recovery after Dupuytren's Fasciectomy.
The study is taking place at Dorset County Hospital and will involve people who are already scheduled for surgery and have a permanent bend of 30 degrees or more in the middle joint of one or more fingers.
The therapy will be given before surgery to see if it helps people get a better result afterwards.
We want to find out:
- Who would be suitable to take part in a future, larger study
- Which results are most important to measure (like finger movement or grip strength)
- How many people complete the full therapy and follow-up We'll also speak to patients and healthcare professionals to understand how acceptable and practical this therapy is.
The goal is to see whether it's possible and worthwhile to run a larger study in the future, to find out if pre-surgery therapy can become a helpful part of treatment for people undergoing Dupuytren's Fasciectomy.
Detailed description
Dupuytren's disease is a common and progressively disabling condition affecting the connective tissue of the palm of the hand. It causes fibrosis of the palmar fascia, which can lead to one or more fingers becoming incapable of full extension, adopting a fixed flexion contracture. This loss of extension can significantly impair hand function and limit daily activities. While surgery (typically fasciectomy) remains the most effective treatment for Dupuytren's contracture, outcomes are often less favourable when the deformity involves the proximal interphalangeal joint, particularly in severe cases where the contracture exceeds 30 degrees.
This feasibility study investigates whether a short course of preoperative therapy, delivered before surgery, can help improve recovery and outcomes after Dupuytren's Fasciectomy. The intervention includes:
- Heat application
- Stretching and massage
- Serial casting - a method of gently lengthening tight tissue by applying and adjusting a soft cast weekly prior to surgery The treatment is designed to gently lengthen tight tissues and increase joint range of movement in the affected fingers prior to surgery, with the goal of improving movement and function after surgery.
We are recruiting approximately 20 adult patients from Dorset County Hospital NHS Foundation Trust who:
- Are scheduled for Dupuytren's Fasciectomy
- Have a PIP joint contracture of 30 degrees or more
Participants will be randomly assigned to one of two groups:
- Intervention group: Will receive the four-week preoperative therapy programme plus an education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones.
- Control group: Will receive the same education programme only, with no added preoperative therapy.
After surgery, all participants will follow standard postoperative therapy and attend follow-up appointments up to 12 weeks post-op, where we will collect outcome measures including:
- Finger range of motion
- Hand function (using the Michigan Hand Outcomes Questionnaire - MHQ)
- Grip strength
- Patient satisfaction
- Completion and retention rates throughout the study To understand how practical and acceptable this approach is in real-world clinical settings, we will also conduct interviews with patients and healthcare professionals to explore their experiences and suggestions for improvement.
As a feasibility study, the goal is not to test effectiveness, but to assess whether a larger, definitive trial is achievable. Specifically, we aim to:
- Determine who is suitable and willing to take part
- Identify the most relevant outcome measures
- Evaluate participation and follow-up rates
- Understand acceptability from both patients and clinicians
- Estimate the resources and planning needed for a full-scale trial If this study shows that the intervention is feasible and well-received, we aim to proceed with a multi-centre randomised controlled trial to evaluate the effectiveness of preoperative therapy as part of standard care for Dupuytren's fasciectomy.
This research is a collaboration between Dorset County Hospital NHS Foundation Trust and Bournemouth University, with active involvement and guidance from a Patient and Public Involvement steering group made up of individuals with lived experience of Dupuytren's disease and the healthcare professionals involved in their care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomised feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Preoperative casting interventionA serial casting intervention protocol involving the application of heat, stretching, and massage before casting. This is repeated weekly for four weeks, with the cast removed and reapplied each time to promote gradual elongation of restricted tissue. Additionally, they will receive an education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones. |
| Control group | No intervention | –An education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones only, with no added preoperative therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participants aged 18 years or older.
- One or more fingers with a Dupuytren's flexion contracture greater than 30° at the PIP joint.
- Awaiting fasciectomy surgery for Dupuytren's contracture.
- Willing and able to provide informed consent for participation in the study.
Key exclusion criteria (5 listed)
- Individuals awaiting needle fasciotomy, dermofasciectomy, or segmental fasciectomy.
- A history of previous treatment for Dupuytren's contracture (e.g., surgery, collagenase injection, or needle fasciectomy) to the study reference digit.
- A history of any other pre-existing hand disorder causing significant movement restriction, pain, or affecting hand function (e.g., post-traumatic stiffness, arthritis, infection).
- Non-English speaking participants due to the need for completing multiple questionnaires that have not been validated in multiple languages.
- Inability to attend follow-up appointments within the required timeframes.
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 |
|---|---|---|
| Preoperative casting interventionA serial casting intervention protocol involving the application of heat, stretching, and massage before casting. This is repeated weekly for four weeks, with the cast removed and reapplied each time to promote gradual elongation of restricted tissue. | Other | Intervention group |
Primary outcome
Progression criteria assessment
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Primary Outcome Measure: Feasibility of progressing to a full randomised controlled trial (RCT) based on predefined progression criteria across eight domains. These include participant availability (≥37 listed for fasciectomy over 9 months), eligibility rate (≥54%), consent rate among eligible participants (≥80%), and willingness to undergo randomisation (≥80%). Additional feasibility indicators include the ability to maintain blinding of assessors and surgeons throughout the study, high intervention acceptability determined via qualitative evaluation, adherence to preoperative splinting (>80%), and retention at 12-week follow-up (>80%). Safety is assessed by tracking adverse events, with progression supported if ≤20% of participants experience an adverse reaction. Thresholds for "Go," "Amend," or "Stop" decisions are defined for each domain.
7 secondary outcomes
Active range of movement of the affected finger(s)
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Passive range of movement (PROM) of the affected finger(s)
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Grip strength of the affected hand
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Michigan Hand Questionnaire (MHQ)
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Patient-Specific Functional Scale (PSFS)
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Barriers and facilitators to adherence
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Sample size estimation
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Background: PubMed 37061720Mellor K, Albury C, Dutton SJ, Eldridge S, Hopewell S. Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting. Pilot Feasibility Stud. 2023 Apr 15;9(1):59. doi: 10.1186/s40814-023-01291-5.
- Individual participant dataSharing planned: Yes. The findings of the trial will be made publicly available through publication or other dissemination tools without any unnecessary delay. Datasets will be made available by the corresponding author on reasonable request and in accordance with consent and ethical approval.
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.
Carol Clark contact
Timothy Crook principal investigator
Dorchester County Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative casting intervention in people with Dupuytren&Amp;#39;s Contracture and Dupuytren&Amp;#39;s Fasciectomy, run by Bournemouth University 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tahra Babiker-Moore (+447974709699, tbabikermoore@bournemouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression criteria assessment (time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07024576, which also lists 1 linked publication.
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 17 Jun 2025.