Dupuytren ContractureNCT03155854
The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring
A study testing Pretendinous cord excision and Division/manipulation of the cord in people with Dupuytren Contracture, run by Mayo Clinic at 1 site in United States.
Trial summary
Research is instrumental for improving medical care and the patient experience. Finding new surgical techniques can create better outcomes and minimize recovery time and complications for patients. 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?
- Pretendinous cord excision and Division/manipulation of the cord
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 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
- Potential candidates for the study will be selected based upon clinical diagnosis of trigger finger with co-existing pretendinous cord. All potential subjects will have either failed non operative treatment or elected surgical treatment.
Who cannot join
- <18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sanjeev Kakar, MD contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring for Dupuytren's Contracture Patients With Pretendinous Cord - Prospective Randomized Clinical Study (Pilot)
Research is instrumental for improving medical care and the patient experience. Finding new surgical techniques can create better outcomes and minimize recovery time and complications for patients. Some patients undergoing trigger finger surgery with a pre-existing Dupuytren's cord may develop a thickened surgical scar after surgery, which can cause discomfort, difficulty with moving or using, and other complications in the affected finger(s) or hand. The investigator is investigating a surgical technique to minimize these potential complications and scarring after surgery.
Subjects are being asked to take part in this research study because they have been diagnosed with trigger finger and pretendinous Dupuytren's cord and have decided to undergo surgery rather than try medical treatment.
Read the detailed description
Patients who have surgery for trigger finger with a thickened overlying Dupuytren's cord are at risk for complications including but not limited to scarring, adhesions, stiffness, injury to underlying structures such as blood vessels, tendons and nerves, loss of motion, pain, bowstringing, and recurrent triggering or contracture. They have been shown to have higher risk for these complications including a thickened scar response. The cause for this is not fully understood, but it could be because the pretendinous cord was cut and not removed. By cutting and not removing this pretendinous cord, this may cause extra scarring that may lead to a thicker palmar scar that may become symptomatic. This study will investigate a different surgical method for relieving the tension caused by a pretendinous cord and whether it reduces complications and scarring.
- Conditions
- Dupuytren Contracture
- Being tested
- Pretendinous cord excision, Division/manipulation of the cord
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pretendinous cord excisionProcedure or surgery
The cord/palmar fascia will be excised during surgery.
Division/manipulation of the cordProcedure or surgery
The pretendinous cord will be divided and incised during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pretendinous cord excision | Active comparator | Patients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be excised Receives: Procedure: Pretendinous cord excision |
| Division/manipulation of the cord | Active comparator | patients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be incised. Receives: Procedure: Division/manipulation of the cord |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scar Progression as measured by the Vancouver Scar Scale
The Vancouver Scar Scale assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. Patient perception of his or her respective scars is not factored in to the overall score. The scores can range from 0 (normal) to 13 (severe scarring).
Measured: baseline, up to 1 year
Change in Scar Progression as measured by the Patient and Observer Scar Assessment Scale
The Patient and Observer Scar Assessment Scale consists of two parts: a Patient Scale and an Observer Scale. Both scales contain seven items that are scored numerically on a 10-step scale. Together they make up the 'Total Score' of the Patient and Observer Scale. The total score can range from 14 (normal) to 140 (worst scar imaginable).
Measured: baseline, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startSep 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 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.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjeev (Sanj) Kakar, M.D., M.B.A., Mayo Clinic
- Investigators
- Sanjeev Kakar, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155854
- Sponsor's protocol ID
- 15-008280
- Status last verified
- Mar 2026
- First submitted
- 7 Oct 2016
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring for Dupuytren's Contracture Patients With Pretendinous Cord - Prospective Randomized Clinical Study (Pilot)
- ClinicalTrials.gov ID
- NCT03155854
- Acronym / sponsor ID
- 15-008280
- Conditions
- Dupuytren Contracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 2017 (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.
Research is instrumental for improving medical care and the patient experience. Finding new surgical techniques can create better outcomes and minimize recovery time and complications for patients. Some patients undergoing trigger finger surgery with a pre-existing Dupuytren's cord may develop a thickened surgical scar after surgery, which can cause discomfort, difficulty with moving or using, and other complications in the affected finger(s) or hand. The investigator is investigating a surgical technique to minimize these potential complications and scarring after surgery.
Subjects are being asked to take part in this research study because they have been diagnosed with trigger finger and pretendinous Dupuytren's cord and have decided to undergo surgery rather than try medical treatment.
Detailed description
Patients who have surgery for trigger finger with a thickened overlying Dupuytren's cord are at risk for complications including but not limited to scarring, adhesions, stiffness, injury to underlying structures such as blood vessels, tendons and nerves, loss of motion, pain, bowstringing, and recurrent triggering or contracture. They have been shown to have higher risk for these complications including a thickened scar response. The cause for this is not fully understood, but it could be because the pretendinous cord was cut and not removed. By cutting and not removing this pretendinous cord, this may cause extra scarring that may lead to a thicker palmar scar that may become symptomatic. This study will investigate a different surgical method for relieving the tension caused by a pretendinous cord and whether it reduces complications and scarring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pretendinous cord excision | Active comparator | Procedure: Pretendinous cord excisionPatients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be excised |
| Division/manipulation of the cord | Active comparator | Procedure: Division/manipulation of the cordpatients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be incised. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Potential candidates for the study will be selected based upon clinical diagnosis of trigger finger with co-existing pretendinous cord. All potential subjects will have either failed non operative treatment or elected surgical treatment.
Key exclusion criteria (1 listed)
- <18 years of age
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 |
|---|---|---|
| Pretendinous cord excisionThe cord/palmar fascia will be excised during surgery. | Procedure or surgery | Pretendinous cord excision |
| Division/manipulation of the cordThe pretendinous cord will be divided and incised during surgery. | Procedure or surgery | Division/manipulation of the cord |
Primary outcome
Change in Scar Progression as measured by the Vancouver Scar Scale
Time frame: baseline, up to 1 year
The Vancouver Scar Scale assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. Patient perception of his or her respective scars is not factored in to the overall score. The scores can range from 0 (normal) to 13 (severe scarring).
Change in Scar Progression as measured by the Patient and Observer Scar Assessment Scale
Time frame: baseline, up to 1 year
The Patient and Observer Scar Assessment Scale consists of two parts: a Patient Scale and an Observer Scale. Both scales contain seven items that are scored numerically on a 10-step scale. Together they make up the 'Total Score' of the Patient and Observer Scale. The total score can range from 14 (normal) to 140 (worst scar imaginable).
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 16 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Sanjeev Kakar, MD contact
Sanjeev Kakar, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pretendinous cord excision and Division/manipulation of the cord in people with Dupuytren Contracture, run by Mayo Clinic at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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 States. 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 Sanjeev Kakar, MD (Kakar.Sanjeev@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scar Progression as measured by the Vancouver Scar Scale (time frame: baseline, up to 1 year). 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 16 Mar 2026.