Dupuytren ContractureDC-USNCT06788847
Evaluating Ultrasound-Guided Needle Knife for Dupuytren's Contracture
A study testing Ultrasound guided needle knife dissection in people with Dupuytren Contracture, run by Mohamed Maher Ismail Ahmed Elashmawy at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy and safety of ultrasound-guided needle knife dissection in treating Dupuytren's contracture. The procedure is designed to improve hund function and minimize complications associated with the conventional surgical methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Contracture
- What is being tested?
- Ultrasound guided needle knife dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2025to 19 Jan 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
- Participants diagnosed with Dupuytren's Contracture.
- Willing to undergo ultrasound-guided needle knife dissection
Who cannot join
- Patients who have undergone previous surgery or needle apponeurotomy for Dupuytren's Contracture on the same hand.
- Active hand infections, open wounds, or dermatological conditions in the treatment area.
- Coagulopathy or use of anticoagulant that cannot be safely paused
- Neuromuscular disorders affecting hand function
- Pregnancy or breastfeeding
- Uncontrolled systemic illnesses, such as poorly managed diabetes or cardiovascular disease.
- Known hypersensitivity to local anesthetics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516
Mohamed Maher Elashmawy, MD, PHD., +201004303100, mohamedmaherismail@mans.edu.eg
About this study
Official title: Advancing Dupuytren's Contracture Treatment: a Clinical Prospective Study on Ultrasound-Guided Needle Knife Dissection
This study aims to evaluate the efficacy and safety of ultrasound-guided needle knife dissection in treating Dupuytren's contracture. The procedure is designed to improve hund function and minimize complications associated with the conventional surgical methods.
Read the detailed description
Dupuytren's contracture is a disease mainly characterized by the progressive fibrosis of the palmar fascia with subsequent hand deformity and dysfunction. The current study seeks to explore, through this minimally invasive technique, ultrasound-guided needle knife dissection regarding ROM and patient satisfaction. The procedure will be carried out under ultrasound guidance to ensure safety and completeness with the accuracy of precise dissection. Primary outcome measures will concern hand mobility, and secondary measures will evaluate patient self-reported satisfaction and any complications for the 6-month follow-up period.
- Conditions
- Dupuytren Contracture
- Being tested
- Ultrasound guided needle knife dissection
- Keywords
- Ultrasound-Guided Procedure, Dupuytrene's Contracture, Tubiana Grade, Fibrotic Cords Acupotomy, Functional Hand Recovery, Palmar Fascia Fibrosis
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided needle knife dissectionProcedure or surgery
Also called UGNK procedure
This procedure involves a minimally invasive dissection of the fibrous cords in Dupuytren's Contracture using a needle knife guided by ultrasound imaging. Local anesthesia using 3-5 ml of 1% Lidocaine and 0.25% bupivacaine is administered for patient comfort. The technique aims to improve precision, minimize complications and reduce recurrence.
Device: Sonosite M-Turbo Ultrasound Machine with Linear Probe HFL38x (6-13 MHz) is used for real-time imaging during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Ultrasound-Guided Needle Knife Dissection | Experimental | Participants in this group will undergo ultrasound-guided needle knife dissection for the treatment of Dupuytren's Contracture. Local anesthesia using 3-5ml of 1% lidocaine 0.25% bupivacaine is administered for patient comfort. This procedure is designed to improve hand function with minimal complications. Receives: Procedure: Ultrasound guided needle knife dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in hand Function
Functional Improvement:
- Evaluated using the QuickDASH score (0-100 scale).
Measured: 6 months
Improvement in hand mobility
Range of Motion (ROM):
- Measurment of joint mobility in degrees at MCP and PIP joints by goniometer.
Measured: 6 months
Secondary outcomes (2)
Patient Satisfaction
Evaluation of patient-reported satisfaction using a standardized questionnaire.
Measured: 6 months
Rate of procedure-related complications
Monitoring and documentation of procedure-related complications, including infection, nerve injury, and other adverse events.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start19 Jan 2025
- Primary completion19 Jul 2025 (estimated)
- Study completion19 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo ultrasound-guided needle knife dissection for Dupuytren's Contracture treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Maher Ismail Ahmed Elashmawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Maher Ismail Ahmed Elashmawy, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788847
- Sponsor's protocol ID
- MansouraUH_DC-US_2025
- Other IDs
- R.24.12.2966
- Acronym
- DC-US
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared to ensure participant confidentiality and comply with ethical and institutional regulations. The collected data will only be used for the purposes of this study and will not be disclosed to external parties
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Dupuytren's Contracture Treatment: a Clinical Prospective Study on Ultrasound-Guided Needle Knife Dissection
- ClinicalTrials.gov ID
- NCT06788847
- Acronym / sponsor ID
- DC-US / MansouraUH_DC-US_2025
- Conditions
- Dupuytren Contracture
- Keywords
- Ultrasound-Guided Procedure, Dupuytrene's Contracture, Tubiana Grade, Fibrotic Cords Acupotomy, Functional Hand Recovery, Palmar Fascia Fibrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mohamed Maher Ismail Ahmed ElashmawyUniversity, hospital or other
- Study start
- 19 Jan 2025 (actual)
- Primary completion
- 19 Jul 2025 (estimated)
- Study completion
- 19 Jan 2026 (estimated)
- First posted
- 23 Jan 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.
This study aims to evaluate the efficacy and safety of ultrasound-guided needle knife dissection in treating Dupuytren's contracture. The procedure is designed to improve hund function and minimize complications associated with the conventional surgical methods.
Detailed description
Dupuytren's contracture is a disease mainly characterized by the progressive fibrosis of the palmar fascia with subsequent hand deformity and dysfunction. The current study seeks to explore, through this minimally invasive technique, ultrasound-guided needle knife dissection regarding ROM and patient satisfaction. The procedure will be carried out under ultrasound guidance to ensure safety and completeness with the accuracy of precise dissection. Primary outcome measures will concern hand mobility, and secondary measures will evaluate patient self-reported satisfaction and any complications for the 6-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo ultrasound-guided needle knife dissection for Dupuytren's Contracture treatment.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Ultrasound-Guided Needle Knife Dissection | Experimental | Procedure: Ultrasound guided needle knife dissectionParticipants in this group will undergo ultrasound-guided needle knife dissection for the treatment of Dupuytren's Contracture. Local anesthesia using 3-5ml of 1% lidocaine 0.25% bupivacaine is administered for patient comfort. This procedure is designed to improve hand function with minimal complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants diagnosed with Dupuytren's Contracture.
- Willing to undergo ultrasound-guided needle knife dissection
Key exclusion criteria (7 listed)
- Patients who have undergone previous surgery or needle apponeurotomy for Dupuytren's Contracture on the same hand.
- Active hand infections, open wounds, or dermatological conditions in the treatment area.
- Coagulopathy or use of anticoagulant that cannot be safely paused
- Neuromuscular disorders affecting hand function
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Ultrasound guided needle knife dissectionAlso: UGNK procedureThis procedure involves a minimally invasive dissection of the fibrous cords in Dupuytren's Contracture using a needle knife guided by ultrasound imaging. Local anesthesia using 3-5 ml of 1% Lidocaine and 0.25% bupivacaine is administered for patient comfort. The technique aims to improve precision, minimize complications and reduce recurrence. Device: Sonosite M-Turbo Ultrasound Machine with Linear Probe HFL38x (6-13 MHz) is used for real-time imaging during the procedure. | Procedure or surgery | Intervention Group: Ultrasound-Guided Needle Knife Dissection |
Primary outcome
Improvement in hand Function
Time frame: 6 months
Functional Improvement: - Evaluated using the QuickDASH score (0-100 scale).
Improvement in hand mobility
Time frame: 6 months
Range of Motion (ROM): - Measurment of joint mobility in degrees at MCP and PIP joints by goniometer.
2 secondary outcomes
Patient Satisfaction
Time frame: 6 months
Rate of procedure-related complications
Time frame: 6 months
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 27 Jan 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared to ensure participant confidentiality and comply with ethical and institutional regulations. The collected data will only be used for the purposes of this study and will not be disclosed to external parties
Related trials for Dupuytren Contracture
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided needle knife dissection in people with Dupuytren Contracture, run by Mohamed Maher Ismail Ahmed Elashmawy at 1 site in Egypt.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Jan 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 Egypt. 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 Mohamed Maher Elashmawy, MD, PHD. (+201004303100, mohamedmaherismail@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in hand Function (time frame: 6 months). The study lists 2 primary outcomes in all. 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 27 Jan 2025.