Dupuytren's DiseaseREMEDYNCT05067764
Efficacy of Aponeurectomy on the 2-year Recurrence Rate of Dupuytren's Disease
A study testing Aponeurectomy with grafting and Aponeurectomy alone in people with Dupuytren's Disease, run by Elsan at 2 sites in France.
Trial summary
Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Disease
- What is being tested?
- Aponeurectomy with grafting and Aponeurectomy alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Sep 2022to 29 Mar 2030
- 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
- Age ≥ 18 years
- Carrier of Tubiana stage II-IV Dupuytren's disease on at least one or more rays, not previously operated
- Indication of a surgery by aponeurectomy
- Skin pinch of the posterior aspect of the arm of more than 1cm
- Affiliation to a social security system
- Patient informed of the study and having given informed consent
Who cannot join
- Previous surgery of any kind for Dupuytren's disease
- Involvement on the thumb only
- Need for a total skin graft or a pedicle flap on all the rays to be treated
- Active autoimmune disease
- Previous treatment with collagenase
- Pregnant and breastfeeding women
- Patient under legal protection
- Contraindications to MRI (criteria applicable only for patients from the coordinating center, not applicable for other centers)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Institut Aquitain de la Main
Pessac, 33600
Elias Sawaya, MD, (0)663420278 ext. +33, esawaya.md@gmail.com
Charlène PY, CRA, charlene.py@elsan.care
- Recruiting
Santé Atlantique ELSAN
Saint-Herblain, 44800
Flore-Anne LECOQ, MD, +332 40 95 93 93, recherche.na@elsan.care
About this study
Official title: Multicenter, Randomized, Open-label Study Evaluating the Efficacy of Aponeurectomy Associated With Adipose Tissue Grafting Compared to Aponeurectomy Alone, on the 2-year Recurrence Rate of Dupuytren's Disease (REMEDY).
Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence.
Various medical and surgical treatments are available.
Read the detailed description
Among these treatments, none to date can eliminate recurrences, which are still too frequent.
Open aponeurectomy (consisting of surgical curettage of the fibrotic cords) remains for the moment the reference technique for treating Dupuytren's disease, with recurrences (between 12 and 39%), but less frequent than the needle technique (50 to 85%).
Could the addition of adipose tissue in the resection areas of Dupytren's fibrosis reduce the rate of recurrence (by the inhibitory action of ADCs on myofibroblasts) in addition to reconstructing the hypodermis in the cavity left by the resection of the cords and improving the quality of the scars? The investigators insist on the fact that this is a homotopic and homologous adipose tissue graft, in closed circuit without denaturation or adjuvant products.
Since, to our knowledge, no other team has used "lipofilling" as an adjuvant treatment to the open resection technique of Dupuytren's cords (aponeurectomy), the investigators first conducted a clinical feasibility and safety study on 70 patients between 2012 and 2017 (currently being published by Springer Editions).
The investigators now wish to conduct a prospective comparative study between patients operated by aponeurectomy WITH (experimental group) and WITHOUT (control group) addition of autologous adipose tissue in the resection areas of Dupuytren's cords.
- Conditions
- Dupuytren's Disease
- Being tested
- Aponeurectomy with grafting, Aponeurectomy alone
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aponeurectomy with graftingProcedure or surgery
The lipofilling is performed, once the incisions are closed and is performed with the Puregraft® system.
The fat graft is taken from the posterior, medial and anterior sides of the arm, by skin puncture. Approximately 10 cc are harvested, allowing a reinjection of about 2 cc per digital radius treated. After conditioning, the fat graft is redistributed to the curettage areas through the skin incisions.
Aponeurectomy aloneProcedure or surgery
The patient is installed in dorsal decubitus position and the arm to be treated is anesthetized by axillary block. The procedure is performed in the operating room, respecting all the rules of asepsis and safety in force. A tourniquet is placed on the arm to be treated and inflated to 250mmHg. Broken incisions are then made opposite the cords to be excised, which are located by palpation. Once the noble elements have been identified, the excision of the cords and fibrous nodules can be done as completely as possible. Sometimes an arthrolysis procedure is necessary in order to restore extension to a joint that has been fixed in a flexion position for several years. Skin closure is most often possible by direct suture or by means of local fatty skin flaps. In some cases, the surgeon may use total skin grafts, or directed healing in certain areas where direct skin suture is not possible.
| Study group | Role | What they receive |
|---|---|---|
| Aponeurectomy with grafting | Experimental | The experimental group evaluates the aponeurectomy associated with adipose tissue grafting. Receives: Procedure: Aponeurectomy with grafting |
| Aponeurectomy alone | Active comparator | The control group evaluates the aponeurectomy alone. Receives: Procedure: Aponeurectomy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence rate of Dupuytren's disease
Recurrence being defined as follows: appearance, at 2 years post-op compared to 6 weeks post-op, of a contracture of more than 20 degrees, with palpable cord, on any treated joint.
Measured: 2 Years after intervention
Secondary outcomes (15)
3-year recurrence rate in both groups
Recurrence being defined as follows: Appearance of a contracture of more than 20 degrees, with palpable cord, on any treated joint, at 3 years post-op compared to 6 weeks post-op
Measured: 3 Years after intervention
5-year recurrence rate in both groups
Recurrence being defined as follows: Appearance of a contracture of more than 20 degrees, with palpable cord, on any treated joint, at 5 years post-op compared to 6 weeks post-op
Measured: 5 Years after intervention
Comparison of the appearance of scars in both groups
Use of questionnaire The Patient and Observer Scar Assessment Scale (POSAS). This questionnaire consists of 2 separate scales of 6 items each (one scale for the observer and one scale for the patient). Each item is evaluated on 10 points. The lowest score is "1" which corresponds to the appearance of normal skin. A score of 10 indicates the greatest deviation from normal skin. The total score for each of the scales is obtained by adding the score for each of the 6 items. This total score can vary between 6 and 60 for each of the scales.
Measured: 1 Year after intervention
Comparison of the appearance of scars in both groups
Use of questionnaire The Patient and Observer Scar Assessment Scale (POSAS). This questionnaire consists of 2 separate scales of 6 items each (one scale for the observer and one scale for the patient). Each item is evaluated on 10 points. The lowest score is "1" which corresponds to the appearance of normal skin. A score of 10 indicates the greatest deviation from normal skin. The total score for each of the scales is obtained by adding the score for each of the 6 items. This total score can vary between 6 and 60 for each of the scales.
Measured: 2 Years after intervention
Comparison of the complication rates in both groups
Complications are defined as Hematoma, infection, graft lysis, disunion or nerve damage.
Measured: 1 Week after intervention
Comparison of the complication rates in both groups
Complications are defined as Hematoma, infection, graft lysis, disunion or nerve damage.
Measured: 6 Weeks after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest.
Measured: 1 Year after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest.
Measured: 2 Years after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest.
Measured: 3 Years after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest.
Measured: 5 Years after intervention
Comparison of the effect on quality of life in both groups
Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function.
Measured: 6 Weeks after intervention
Comparison of the effect on quality of life in both groups
Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function.
Measured: 1 Year after intervention
Comparison of the effect on quality of life in both groups
Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function.
Measured: 2 Years after intervention
Comparison of the effect on quality of life in both groups
Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function.
Measured: 5 Years after intervention
Evaluation of the primary endpoint on the second hand operated on.
The surgery being done with or without fat according to the treatment of the 1st randomized hand (cross-over scheme).
Data collection for the second surgery only if it occurs between the 1st hand surgery and the patient's protocol discharge.
Measured: Within five years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start29 Sep 2022
- Primary completion29 Mar 2027 (estimated)
- Study completion29 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Dupuytren's DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, prospective, therapeutic, comparative, randomized controlled open-label, superiority, multicenter, national study.
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias SAWAYA, MD, Principal investigator, Institut Aquitain de la Main
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067764
- Sponsor's protocol ID
- REMEDY
- Other IDs
- 2020-A03214-35
- Acronym
- REMEDY
- Status last verified
- Apr 2026
- First submitted
- 24 Sep 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Selles RW, Zhou C, Kan HJ, Wouters RM, van Nieuwenhoven CA, Hovius SER. Percutaneous Aponeurotomy and Lipofilling versus Limited Fasciectomy for Dupuytren's Contracture: 5-Year Results from a Randomized Clinical Trial. Plast Reconstr Surg. 2018 Dec;142(6):1523-1531. doi: 10.1097/PRS.0000000000004982.
PubMed 30489526Henry M. Dupuytren's disease: current state of the art. Hand (N Y). 2014 Mar;9(1):1-8. doi: 10.1007/s11552-013-9563-0.
PubMed 24570630Engstrand C, Krevers B, Nylander G, Kvist J. Hand function and quality of life before and after fasciectomy for Dupuytren contracture. J Hand Surg Am. 2014 Jul;39(7):1333-1343.e2. doi: 10.1016/j.jhsa.2014.04.029.
PubMed 24969497Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.
PubMed 16936550Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.
PubMed 11304456Mojallal A, Lequeux C, Shipkov C, Breton P, Foyatier JL, Braye F, Damour O. Improvement of skin quality after fat grafting: clinical observation and an animal study. Plast Reconstr Surg. 2009 Sep;124(3):765-774. doi: 10.1097/PRS.0b013e3181b17b8f.
PubMed 19730294Verhoekx JSN, Mudera V, Walbeehm ET, Hovius SER. Adipose-derived stem cells inhibit the contractile myofibroblast in Dupuytren's disease. Plast Reconstr Surg. 2013 Nov;132(5):1139-1148. doi: 10.1097/PRS.0b013e3182a3bf2b.
PubMed 23924646Foucher G, Medina J, Navarro R. Percutaneous needle aponeurotomy: complications and results. J Hand Surg Br. 2003 Oct;28(5):427-31. doi: 10.1016/s0266-7681(03)00013-5.
PubMed 12954251Kan HJ, Verrijp FW, Hovius SER, van Nieuwenhoven CA; Dupuytren Delphi Group; Selles RW. Recurrence of Dupuytren's contracture: A consensus-based definition. PLoS One. 2017 May 15;12(5):e0164849. doi: 10.1371/journal.pone.0164849. eCollection 2017.
PubMed 28505187Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
PubMed 15866967Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17.
PubMed 19297202Sawaya ET, Sommier B, Alet JM, Piechaud PT; REMEDY Study Group; ReSurg; Lecoq FA. Limited fasciectomy with versus without autologous adipose tissue grafting for treatment of Dupuytren's contracture (REMEDY): study protocol for a multicentre randomised controlled trial. Trials. 2024 Sep 2;25(1):577. doi: 10.1186/s13063-024-08410-4.
PubMed 39223657
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open-label Study Evaluating the Efficacy of Aponeurectomy Associated With Adipose Tissue Grafting Compared to Aponeurectomy Alone, on the 2-year Recurrence Rate of Dupuytren's Disease (REMEDY).
- ClinicalTrials.gov ID
- NCT05067764
- Acronym / sponsor ID
- REMEDY / REMEDY
- Conditions
- Dupuytren's Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 29 Mar 2027 (estimated)
- Study completion
- 29 Mar 2030 (estimated)
- First posted
- 5 Oct 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.
Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence.
Various medical and surgical treatments are available.
Detailed description
Among these treatments, none to date can eliminate recurrences, which are still too frequent.
Open aponeurectomy (consisting of surgical curettage of the fibrotic cords) remains for the moment the reference technique for treating Dupuytren's disease, with recurrences (between 12 and 39%), but less frequent than the needle technique (50 to 85%).
Could the addition of adipose tissue in the resection areas of Dupytren's fibrosis reduce the rate of recurrence (by the inhibitory action of ADCs on myofibroblasts) in addition to reconstructing the hypodermis in the cavity left by the resection of the cords and improving the quality of the scars? The investigators insist on the fact that this is a homotopic and homologous adipose tissue graft, in closed circuit without denaturation or adjuvant products.
Since, to our knowledge, no other team has used "lipofilling" as an adjuvant treatment to the open resection technique of Dupuytren's cords (aponeurectomy), the investigators first conducted a clinical feasibility and safety study on 70 patients between 2012 and 2017 (currently being published by Springer Editions).
The investigators now wish to conduct a prospective comparative study between patients operated by aponeurectomy WITH (experimental group) and WITHOUT (control group) addition of autologous adipose tissue in the resection areas of Dupuytren's cords.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, prospective, therapeutic, comparative, randomized controlled open-label, superiority, multicenter, national study.
| Arm | Type | Receives |
|---|---|---|
| Aponeurectomy with grafting | Experimental | Procedure: Aponeurectomy with graftingThe experimental group evaluates the aponeurectomy associated with adipose tissue grafting. |
| Aponeurectomy alone | Active comparator | Procedure: Aponeurectomy aloneThe control group evaluates the aponeurectomy alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Carrier of Tubiana stage II-IV Dupuytren's disease on at least one or more rays, not previously operated
- Indication of a surgery by aponeurectomy
- Skin pinch of the posterior aspect of the arm of more than 1cm
- Affiliation to a social security system
Key exclusion criteria (8 listed)
- Previous surgery of any kind for Dupuytren's disease
- Involvement on the thumb only
- Need for a total skin graft or a pedicle flap on all the rays to be treated
- Active autoimmune disease
- Previous treatment with collagenase
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 |
|---|---|---|
| Aponeurectomy with graftingThe lipofilling is performed, once the incisions are closed and is performed with the Puregraft® system. The fat graft is taken from the posterior, medial and anterior sides of the arm, by skin puncture. Approximately 10 cc are harvested, allowing a reinjection of about 2 cc per digital radius treated. After conditioning, the fat graft is redistributed to the curettage areas through the skin incisions. | Procedure or surgery | Aponeurectomy with grafting |
| Aponeurectomy aloneThe patient is installed in dorsal decubitus position and the arm to be treated is anesthetized by axillary block. The procedure is performed in the operating room, respecting all the rules of asepsis and safety in force. A tourniquet is placed on the arm to be treated and inflated to 250mmHg. Broken incisions are then made opposite the cords to be excised, which are located by palpation. Once the noble elements have been identified, the excision of the cords and fibrous nodules can be done as completely as possible. Sometimes an arthrolysis procedure is necessary in order to restore extension to a joint that has been fixed in a flexion position for several years. Skin closure is most often possible by direct suture or by means of local fatty skin flaps. In some cases, the surgeon may use total skin grafts, or directed healing in certain areas where direct skin suture is not possible. | Procedure or surgery | Aponeurectomy alone |
Primary outcome
2-year recurrence rate of Dupuytren's disease
Time frame: 2 Years after intervention
Recurrence being defined as follows: appearance, at 2 years post-op compared to 6 weeks post-op, of a contracture of more than 20 degrees, with palpable cord, on any treated joint.
15 secondary outcomes
3-year recurrence rate in both groups
Time frame: 3 Years after intervention
5-year recurrence rate in both groups
Time frame: 5 Years after intervention
Comparison of the appearance of scars in both groups
Time frame: 1 Year after intervention
Comparison of the appearance of scars in both groups
Time frame: 2 Years after intervention
Comparison of the complication rates in both groups
Time frame: 1 Week after intervention
Comparison of the complication rates in both groups
Time frame: 6 Weeks after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Time frame: 1 Year after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Time frame: 2 Years after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Time frame: 3 Years after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Time frame: 5 Years after intervention
Comparison of the effect on quality of life in both groups
Time frame: 6 Weeks after intervention
Comparison of the effect on quality of life in both groups
Time frame: 1 Year after intervention
Comparison of the effect on quality of life in both groups
Time frame: 2 Years after intervention
Comparison of the effect on quality of life in both groups
Time frame: 5 Years after intervention
Evaluation of the primary endpoint on the second hand operated on.
Time frame: Within five years after intervention
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 23 Apr 2026.
- Background: PubMed 30489526Selles RW, Zhou C, Kan HJ, Wouters RM, van Nieuwenhoven CA, Hovius SER. Percutaneous Aponeurotomy and Lipofilling versus Limited Fasciectomy for Dupuytren's Contracture: 5-Year Results from a Randomized Clinical Trial. Plast Reconstr Surg. 2018 Dec;142(6):1523-1531. doi: 10.1097/PRS.0000000000004982.
- Background: PubMed 24570630Henry M. Dupuytren's disease: current state of the art. Hand (N Y). 2014 Mar;9(1):1-8. doi: 10.1007/s11552-013-9563-0.
- Background: PubMed 24969497Engstrand C, Krevers B, Nylander G, Kvist J. Hand function and quality of life before and after fasciectomy for Dupuytren contracture. J Hand Surg Am. 2014 Jul;39(7):1333-1343.e2. doi: 10.1016/j.jhsa.2014.04.029.
- Background: PubMed 16936550Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.
- Background: PubMed 11304456Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.
- Background: PubMed 19730294Mojallal A, Lequeux C, Shipkov C, Breton P, Foyatier JL, Braye F, Damour O. Improvement of skin quality after fat grafting: clinical observation and an animal study. Plast Reconstr Surg. 2009 Sep;124(3):765-774. doi: 10.1097/PRS.0b013e3181b17b8f.
- Background: PubMed 23924646Verhoekx JSN, Mudera V, Walbeehm ET, Hovius SER. Adipose-derived stem cells inhibit the contractile myofibroblast in Dupuytren's disease. Plast Reconstr Surg. 2013 Nov;132(5):1139-1148. doi: 10.1097/PRS.0b013e3182a3bf2b.
- Background: PubMed 12954251Foucher G, Medina J, Navarro R. Percutaneous needle aponeurotomy: complications and results. J Hand Surg Br. 2003 Oct;28(5):427-31. doi: 10.1016/s0266-7681(03)00013-5.
- Background: PubMed 28505187Kan HJ, Verrijp FW, Hovius SER, van Nieuwenhoven CA; Dupuytren Delphi Group; Selles RW. Recurrence of Dupuytren's contracture: A consensus-based definition. PLoS One. 2017 May 15;12(5):e0164849. doi: 10.1371/journal.pone.0164849. eCollection 2017.
- Background: PubMed 15866967Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
- Background: PubMed 19297202Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17.
- Derived from this study: PubMed 39223657Sawaya ET, Sommier B, Alet JM, Piechaud PT; REMEDY Study Group; ReSurg; Lecoq FA. Limited fasciectomy with versus without autologous adipose tissue grafting for treatment of Dupuytren's contracture (REMEDY): study protocol for a multicentre randomised controlled trial. Trials. 2024 Sep 2;25(1):577. doi: 10.1186/s13063-024-08410-4.
- 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.
Elias SAWAYA, MD principal investigator
Institut Aquitain de la Main
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aponeurectomy with grafting and Aponeurectomy alone in people with Dupuytren's Disease, run by Elsan at 2 sites in France.
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 6 inclusion and 8 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Elias SAWAYA, MD ((0)663420278 ext. +33, esawaya.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence rate of Dupuytren's disease (time frame: 2 Years after intervention). 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 NCT05067764, which also lists 12 linked publications.
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 23 Apr 2026.