Hallux AbductovalgusDYNHALLUXNCT04732897
Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus (DYNHALLUX)
A study testing dynamic dressing in people with Hallux Abductovalgus, run by Centre Hospitalier Annecy Genevois at 1 site in France.
Trial summary
Hallux Valgus (HV) is a lateral deviation of the big toe. HV is a deformity of the forefoot centered on the 1st radius (1st metatarsal and big toe). This deformation is characterized by: a big toe (hallux) deviated outwards (valgus greater than 12 °) a first metatarsal moved medially (varus) (angle M1 / M2> 10 °). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Abductovalgus
- What is being tested?
- dynamic dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2021to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hallux valgus on at least one foot theoretically requiring surgical management within 12 months
- reducible hallux valgus
- wearing custom-made orthopedic insoles made by a biomechanical podiatrist - SHORE ≥ 65 - for at least 2 months at the time of inclusion
- beneficiary of a social security scheme
- informed of the study and signed informed consent form
Who cannot join
- History of hallux valgus correction surgery on the affected foot
- History of traumatic lesion of the M1-P1 metatarsophalangeal joint of the affected foot
- Skin pathology limiting or contraindicating the possibility of dressings according to the judgment of the investigator (eg dyshidrotic eczema, psoriasis or other problematic skin damage located in the foot)
- Acute bursitis
- Clinical and / or radiological stage 1 or more osteoarthritis according to the criteria of Kellgren and Lawrence
- Non-stabilized diabetes and / or diabetes with micro / macrovascular complications
Show all 14Show fewer
- Patients with neuropathy
- History of gout
- History of rheumatic pathology
- Obliterating arteriopathy of the lower limbs of stage II or more according to the classification of Leriche and Fontaine
- Pregnant woman
- Patients under tutorship or curatorship
- Patients under legal protection
- Patients who do not understand French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus With Theoretical Indication for Surgery: Randomized Open Trial
Hallux Valgus (HV) is a lateral deviation of the big toe. HV is a deformity of the forefoot centered on the 1st radius (1st metatarsal and big toe). This deformation is characterized by:
- a big toe (hallux) deviated outwards (valgus greater than 12 °)
- a first metatarsal moved medially (varus) (angle M1 / M2> 10 °). We also note the existence of an exostosis formed by the apex of the angle between the 1st metatarsal deviated inwards and the big toe deported outwards. This exostosis corresponds to the head of the 1st metatarsal.
Read more
In addition to the pain and the unaesthetic nature induced by this deviation, the modifications of the skeletal axes of the foot cause disorders of its function but also of the joints of the lower limb during standing, walking and running. Axis defects of the lower limbs in varum or valgum also cause deformities in the rearfoot, midfoot and forefoot.
There is no non-surgical curative treatment for this deformity. Different conservative treatment options have been offered for first-line treatment, including different types of physiotherapy, wearing rigid insoles or splints.
Wearing rigid insoles is indicated to "counter" the valgic pressure, thereby reducing pain and high plantar pressure, in patients with HV. Their hardness, expressed in SHORE units, must be greater than 65. By countering the valgic pressure (rearfoot and midfoot), the rigid soles make it possible to contain the development of deformation and stabilize the axis of the first spoke. The speed of hallux deformation is therefore greatly reduced if the soles are worn diligently. But there is little or no impact on the correction of the deformity, but it is stabilized as it is without rapid and major worsening. Indeed, soles with a hardness greater than or equal to 65 SHORE make it possible to avoid the valgum of the hindfoot and midfoot under load and when walking.
Wearing a dynamic splint was studied in a recently published prospective randomized study conducted between 2011 and 2013. This study, concluding that the dynamic splint is not effective in reducing the angle of deformation of the HV, nevertheless shows the reduction in pain during walking and running. The limits of the study lie in the pace of wearing the splint, left to the discretion of patients, during their rest period, and in the duration of the operation, which is not precisely described.
Read the detailed description
The hypothesis of the study is that a dynamic joint dressing, associated with a rigid orthopedic insole, would make it possible to "reverse" the deformation and re-focus the angles of deformation of the first ray in patients with a HV and already stabilized, i.e. wearer of made-to-measure soles with SHORE greater than or equal to 65 for at least 2 months.
- Conditions
- Hallux Abductovalgus
- Being tested
- dynamic dressing
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic dressingProcedure or surgery
Dynamic dressing is made by bandages of the foot with gauze pad, stretchable adhesive tape and elastic compression band
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | wearing made-to-measure soles with SHORE greater than or equal to 65 (standard of care) |
| Interventional arm | Experimental | wearing made-to-measure soles with SHORE greater than or equal to 65 + dynamic dressing of the joint Receives: Procedure: dynamic dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline M1 / P1 angle at day 75 measured by weightbearing foot radiograph
M1 / P1 angle measured before and after intervention
Measured: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75
Secondary outcomes (8)
Variation of the M1 / M2 angle measured by weightbearing foot radiograph
M1 / M2 angle measured before and after intervention
Measured: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75
Variation of the M1 / P1 and M1/M2 angle measured by weightbearing foot radiograph at long time
M1/P1 et M1 / M2 angle measured just at the end of the intervention and at long time
Measured: radiograph at day 75 and at month 6 and month 12
12-month surgery rate
use of surgery 12 months after randomization
Measured: month 12
Quality of life measured by the American Orthopedic Foot and Ankle Society score
American Orthopedic Foot and Ankle Society - hallux metatarsophalangeal interphalangeal scale (min = 0, max = 100, higher scores mean a better outcome).
Measured: day 0, day 75, month 6 and month 12
Quality of life measured by the Foot Function Index score
Foot Fonction Index (min = 0, max = 100, higher scores mean a worse outcome).
Measured: day 0, day 75, month 6 and month 12
Quality of life measured by the EuroQol Visual Analogue Scale
EuroQol Visual Analogue Scale (min = 0, max = 100, higher scores mean a better outcome.
Measured: day 0, day 75, month 6 and month 12
Pain Visual Analogue Scale
Pain Visual Analogue Scale (min = 0, max = 10, higher scores mean a worse outcome).
Measured: day 0, day 75, month 6 and month 12
Physician clinical qualitative assessement of skin condition
Presence or absence of irritation, blisters, redness, itching
Measured: day 0 and day 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start22 Apr 2021
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Why it stopped: Recruitment issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux AbductovalgusStudies 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
- Open-label randomized trial
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy Allamel, PhD, Principal investigator, CH Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732897
- Sponsor's protocol ID
- 18-45
- Acronym
- DYNHALLUX
- Status last verified
- Jul 2022
- First submitted
- 26 Jan 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus With Theoretical Indication for Surgery: Randomized Open Trial
- ClinicalTrials.gov ID
- NCT04732897
- Acronym / sponsor ID
- DYNHALLUX / 18-45
- Conditions
- Hallux Abductovalgus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issue
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 1 Feb 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.
Hallux Valgus (HV) is a lateral deviation of the big toe. HV is a deformity of the forefoot centered on the 1st radius (1st metatarsal and big toe). This deformation is characterized by:
- a big toe (hallux) deviated outwards (valgus greater than 12 °)
- a first metatarsal moved medially (varus) (angle M1 / M2> 10 °). We also note the existence of an exostosis formed by the apex of the angle between the 1st metatarsal deviated inwards and the big toe deported outwards. This exostosis corresponds to the head of the 1st metatarsal.
In addition to the pain and the unaesthetic nature induced by this deviation, the modifications of the skeletal axes of the foot cause disorders of its function but also of the joints of the lower limb during standing, walking and running. Axis defects of the lower limbs in varum or valgum also cause deformities in the rearfoot, midfoot and forefoot.
There is no non-surgical curative treatment for this deformity. Different conservative treatment options have been offered for first-line treatment, including different types of physiotherapy, wearing rigid insoles or splints.
Wearing rigid insoles is indicated to "counter" the valgic pressure, thereby reducing pain and high plantar pressure, in patients with HV. Their hardness, expressed in SHORE units, must be greater than 65. By countering the valgic pressure (rearfoot and midfoot), the rigid soles make it possible to contain the development of deformation and stabilize the axis of the first spoke. The speed of hallux deformation is therefore greatly reduced if the soles are worn diligently. But there is little or no impact on the correction of the deformity, but it is stabilized as it is without rapid and major worsening. Indeed, soles with a hardness greater than or equal to 65 SHORE make it possible to avoid the valgum of the hindfoot and midfoot under load and when walking.
Wearing a dynamic splint was studied in a recently published prospective randomized study conducted between 2011 and 2013. This study, concluding that the dynamic splint is not effective in reducing the angle of deformation of the HV, nevertheless shows the reduction in pain during walking and running. The limits of the study lie in the pace of wearing the splint, left to the discretion of patients, during their rest period, and in the duration of the operation, which is not precisely described.
Detailed description
The hypothesis of the study is that a dynamic joint dressing, associated with a rigid orthopedic insole, would make it possible to "reverse" the deformation and re-focus the angles of deformation of the first ray in patients with a HV and already stabilized, i.e. wearer of made-to-measure soles with SHORE greater than or equal to 65 for at least 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label randomized trial
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –wearing made-to-measure soles with SHORE greater than or equal to 65 (standard of care) |
| Interventional arm | Experimental | Procedure: dynamic dressingwearing made-to-measure soles with SHORE greater than or equal to 65 + dynamic dressing of the joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hallux valgus on at least one foot theoretically requiring surgical management within 12 months
- reducible hallux valgus
- wearing custom-made orthopedic insoles made by a biomechanical podiatrist - SHORE ≥ 65 - for at least 2 months at the time of inclusion
- beneficiary of a social security scheme
- informed of the study and signed informed consent form
Key exclusion criteria (14 listed)
- History of hallux valgus correction surgery on the affected foot
- History of traumatic lesion of the M1-P1 metatarsophalangeal joint of the affected foot
- Skin pathology limiting or contraindicating the possibility of dressings according to the judgment of the investigator (eg dyshidrotic eczema, psoriasis or other problematic skin damage located in the foot)
- Acute bursitis
- Clinical and / or radiological stage 1 or more osteoarthritis according to the criteria of Kellgren and Lawrence
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 |
|---|---|---|
| dynamic dressingDynamic dressing is made by bandages of the foot with gauze pad, stretchable adhesive tape and elastic compression band | Procedure or surgery | Interventional arm |
Primary outcome
Change from baseline M1 / P1 angle at day 75 measured by weightbearing foot radiograph
Time frame: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75
M1 / P1 angle measured before and after intervention
8 secondary outcomes
Variation of the M1 / M2 angle measured by weightbearing foot radiograph
Time frame: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75
Variation of the M1 / P1 and M1/M2 angle measured by weightbearing foot radiograph at long time
Time frame: radiograph at day 75 and at month 6 and month 12
12-month surgery rate
Time frame: month 12
Quality of life measured by the American Orthopedic Foot and Ankle Society score
Time frame: day 0, day 75, month 6 and month 12
Quality of life measured by the Foot Function Index score
Time frame: day 0, day 75, month 6 and month 12
Quality of life measured by the EuroQol Visual Analogue Scale
Time frame: day 0, day 75, month 6 and month 12
Pain Visual Analogue Scale
Time frame: day 0, day 75, month 6 and month 12
Physician clinical qualitative assessement of skin condition
Time frame: day 0 and day 75
Results and safety
The study was stopped early (reason given: Recruitment issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
Related trials for Hallux Abductovalgus
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
RecruitingObservational study
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
Hallux Valgus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Not yet recruitingObservational study
Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery
Postoperative Chronic Pain, Hallux Valgus Surgery
Recruiting
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Hallux Valgus, Orthopedic Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Allamel, PhD principal investigator
CH Annecy Genevois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic dressing in people with Hallux Abductovalgus, run by Centre Hospitalier Annecy Genevois at 1 site 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 22 Jul 2022. 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 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?
The study was stopped early (reason given: Recruitment issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline M1 / P1 angle at day 75 measured by weightbearing foot radiograph (time frame: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75). 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 22 Jul 2022.