MetatarsalgiaNCT05713175
Orthopaedic Treatment in Propulsive Metatarsalgia
A study testing EVA plantar orthosis, Polypropylene plantar orthosis and Fixtoe device in people with Metatarsalgia and Treatment, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The goal of this clinical trial is to compare the effectiveness of two conservative orthopedic treatments in propulsive metatarsalgia. The main question it aims to answer are: To compare the effectiveness of treatments on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metatarsalgia, Treatment, Foot
- What is being tested?
- EVA plantar orthosis, Polypropylene plantar orthosis and Fixtoe device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 1 Jan 2023
- 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
- Mechanical pain in the 2nd or 3rd metatarsophalangeal joint (MTPJ)
- Positive Laschman's drawer test in 2nd or 3rd MTPJ. (CITA)
- Physical exploration revealing pain upon the palpation in plantar plate ( when cranial-caudal pressure was directly applied in the plantar aspect of the 2nd or 3rd MTPJ). (CITA)
- Availability of dorsal-plantar and lateral wheightbearing radiography of the affected foot.
Who cannot join
- Subjects with at least one of the following were excluded.
- Deformity of the 2nr or 3rd metatarsal head (MTH) (Freiberg's disease)
- Morton's neuroma and/or neuritic symptomatlogy y referred.
- Rigid claw or hammer toe (positive Kelikian test) whithin radiographic dislocation of 2nd or 3rd MTPJ. (CITA)
- Dermatological lesión plantar to 2nd or 3rd MTPJ (intractable plantar keratosis (IPK), foot ulcer, plantar wart, etc.)
- Neurological, methabolical, vascular or rheumatological not-controlled systemic disease with potential manifestations in foot and ankle.
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- Previous history of foot or ankle surgery entailing limitations in mobility and/or alterations of the metatarsal parabola.
- Previous history of foot or ankle fracture
- Morpho-functional alteration of the lower limbs: clinical asymmetry greater than 10 mm and presence of asymmetric genu varus or valgus.
- Alterations of the cognitive state preventing to understand the objective of the study and guidelines to follow for their participation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clínica Universitaria de Podología Complutense University Madrid
Madrid, 28040
About this study
Official title: Effectiveness of Orthopaedic Treatment in Propulsive Metatarsalgia
The goal of this clinical trial is to compare the effectiveness of two conservative orthopedic treatments in propulsive metatarsalgia.
The main question it aims to answer are:
- To compare the effectiveness of treatments on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia.
- To determinate the influence of clinical and radiographical characteristics in pain improvement.
Participants will wear the treatment for 3 months . Researchers will compare polypropylene and EVA insoles and Fixtoe Device® to see if a foot pain improvement is achieved.
Read the detailed description
Type of Study: Randomised Clinical Trial.
Aim: To compare the effect of orthopedic treatment on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia.
Study Protocol Description:
Prior to the start of the study, a calculation of the sample size will be made using the GRANMO Sample Size Calculator, version .12 April 2012, with an error of 5%, assuming a confidence level of 95% and values of ß that establish an analysis power of 80%.
The study population will be randomly divided into two treatment groups, which, in turn, will be subdivided into two groups. Said randomization will be carried out using an online tool (www.randomization.com).
Treatment groups are:
- Group A: Treatment by custom insoles made of 4.5mm polypropylene, balanced in inversion 0-4º, MLA of the patient, 4mm-heel rise and metatarsal dome.
- Group A1: Treatment from the date of diagnosis until the start of insoles use (3 weeks) using the Fix-Toe® device.
- Group A2: Without orthopedic treatment from the date of diagnosis until the start of insoles use (3 weeks).
- Group B: Treatment by custom insoles made of 45º shore A E.V.A with the patient's MLA, 4mm- heel rise and metatarsal dome.
- Group B1: Treatment from the date of diagnosis until the start of insoles use (3 weeks) using the Fix-Toe® device.
- Group B2: Without orthopedic treatment from the date of diagnosis until the start of insoles use (3 weeks).
Visits protocol is as follows:
- Day 1: inclusion, clinical and radiographical evaluation. Pain questionnaires fulfillment.Treatment group allocation.
- Day 2 (3 weeks after Day 1): Pain questionnaires fulfillment. Starts insoles treatment.
- Day 3 (6 weeks after Day 2): Pain questionnaires fulfillment (telephone).
- Day 4 (6 weeks after Day 3): Pain questionnaires fulfillment. Clinical evaluation. End of study.
- Conditions
- Metatarsalgia, Treatment, Foot, Foot Diseases, Orthopedic Disorder, Subluxation of Toe Joint
- Being tested
- EVA plantar orthosis, Polypropylene plantar orthosis, Fixtoe device
- Keywords
- Metatarsalgia, Forefoot, Foot Diseases, Treatment
- Medical subject headings
- Metatarsalgia, Foot Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVA plantar orthosisDevice
Treatment consisting of a personalized plantar orthosis fabricated in 45º shore A hardness Ethyl Vinyl Acetate (EVA), which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.
Polypropylene plantar orthosisDevice
Treatment consisting of a personalized plantar orthosis fabricated in 4mm polypropylene, which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.Orthosis fabricated following the inverted orthotic technique.
Fixtoe deviceDevice
Fixtoe Device, simulating the metatarsophalangeal stabilization tape technique is worn for one month, prior to definitive treatment consisting of a personalized plantar orthosis.
| Study group | Role | What they receive |
|---|---|---|
| EVA plantar orthosis | Active comparator | Treatment consisting of a personalized plantar orthosis fabricated in 45º shore A hardness Ethyl Vinyl Acetate (EVA), which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch. Receives: Device: EVA plantar orthosis |
| Polypropylene plantar orthosis | Active comparator | Treatment consisting of a personalized plantar orthosis fabricated in 4mm polypropylene, which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.Orthosis fabricated following the inverted orthotic technique. Receives: Device: Polypropylene plantar orthosis |
| Fixtoe device | Active comparator | Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment. Receives: Device: EVA plantar orthosis; Device: Polypropylene plantar orthosis; Device: Fixtoe device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Pain
Foot Pain measured using a 11-point VAS score. 0 is the lower (better) value and 10 is the higher (worst) value.
Measured: Up to 20 weeks.
Foot Pain and Disability
Measured using the Foot Function Index (FFI-Sp) questionnaire (Spanish version). Higher values mean worse outcome and lower values mean better outcome.
Measured: Up to 20 weeks.
Secondary outcomes (35)
Demographic data: Age.
Expressed in years
Measured: Day 1.
Demographic data: Gender
Women or Men
Measured: Day 1.
Demographic data: Wheight
Expressed in kilograms.
Measured: Day 1.
Demographic data: Height
Expressed in centimetres.
Measured: Day 1.
Demographic data: Body Mass Index (BMI)
Weight and Height will be combined to report BMI in kg/m^2
Measured: Day 1.
Demographic data: Adherence to treatment
Good / Bad. Measured using a own questionnaire.
Measured: Day 2, Day 3, Day 4.
Demographic data: Time with symptoms.
>12 months / 6-12 months / > 6 months / > 3 months
Measured: Day 1.
Foot clinical evaluation data: Toes deformity
No deformity / Sagittal plane deformity / V sign
Measured: Day 1.
Foot clinical evaluation data: Paper pull-out test
No resistence / Medium resistence / Resistence
Measured: Day 1, Day 2.
Foot clinical evaluation data: 1st metatarsophalangeal joint range of movement
Expressed in degrees.
Measured: Day 1, Day 4
Foot clinical evaluation data: Medial column of the foot stiffness
Low / Moderate/ High
Measured: Day 1.
Foot clinical evaluation data: Functional Hallux Limitus
Yes / No. According to Functional Hallux Limitus test.
Measured: Day 1.
Foot clinical evaluation data: First ray mobility
Dorsal > Plantar / Similar / Dorsal < Plantar
Measured: Day 1.
Foot clinical evaluation data: Lunge test
Positive / Negative
Measured: Day 1.
Foot clinical evaluation data: Arch index
Expressed in degrees.
Measured: Day 1, Day 4.
Foot clinical evaluation data: Navicular Drop Test
Expressed in centimetres.
Measured: Day 1, Day 4.
Foot clinical evaluation data: Calcaneus relaxed standing position.
Expressed in degrees.
Measured: Day 1, Day 4.
Foot clinical evaluation data: Subtalar joint axis orientation
Medial / Neutral / Lateral
Measured: Day 1.
Radiographical data: HAV angle
Expressed in degrees.
Measured: Day 1.
Radiographical data: 1st metatarsophalangeal joint osteoarthritis
0/ 1/ 2/ 3/ 4
Measured: Day 1.
Metatarsal formula
According to the length of the metatarsal bones.
Measured: Day 1.
Radiographical data: 2nd metatarsophalangeal joint angle
Expressed in degrees.
Measured: Day 1.
Radiographical data: 3rd metatarsophalangeal joint angle
Expressed in degrees.
Measured: Day 1.
Radiographical data: M1-M2 intermetatarsal angle
Expressed in degrees.
Measured: Day 1.
Radiographical data: 2nd- 3rd metatarsophalangeal joint impingement
Yes / No
Measured: Day 1.
Radiographical data: 2nd - 3rd metatatsophalangeal joint radiolucency.
Yes / No
Measured: Day 1.
Radiographical data: Metatarsus primus elevatus
Yes / No
Measured: Day 1.
Radiographical data: 1st cuneiform - 2nd metatarsal gap
Expressed in centimetres.
Measured: Day 1.
Radiographical data: talar coverage angle
Expressed in degrees.
Measured: Day 1.
Radiographical data: 1st cuneiform - 5th metatarsal distance
Expressed in centimetres.
Measured: Day 1.
Radiographical data: Meary's line
Dorsal / Plantar
Measured: Day 1.
Foot orthosis data: Metatarsal dome location in relation to central metatarsal heads
Similar / Distal / Proximal
Measured: Day 4.
Foot orthosis data: Metatarsal dome location in relation to 1st metatarsal head
Similar / Distal / Proximal
Measured: Day 4.
Foot orthosis data: Stability
Yes / No
Measured: Day 4.
Foot orthosis data: Orthotic deformity test
Yes / No
Measured: Day 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetatarsalgiaStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Model description
- Parallel Groups Open Randomised Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ángel M Orejana-García, PhD, Study director, Complutense University MadridRaúl J Molines-Barroso, PhD, Study director, Complutense University MadridJosé Luis Lázaro-Martínez, PhD, Study director, Complutense University MadridMaria Ruiz-Ramos, MSc, Principal investigator, Complutense University Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713175
- Sponsor's protocol ID
- Tesis Doc Maria Ruiz-Ramos
- Status last verified
- Jan 2023
- First submitted
- 5 Oct 2022
- Last updated
- 6 Feb 2023
- 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Orthopaedic Treatment in Propulsive Metatarsalgia
- ClinicalTrials.gov ID
- NCT05713175
- Acronym / sponsor ID
- Tesis Doc Maria Ruiz-Ramos
- Conditions
- Metatarsalgia, Treatment, Foot, Foot Diseases, Orthopedic Disorder, Subluxation of Toe Joint
- Keywords
- Metatarsalgia, Forefoot, Foot Diseases, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 6 Feb 2023 (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.
The goal of this clinical trial is to compare the effectiveness of two conservative orthopedic treatments in propulsive metatarsalgia.
The main question it aims to answer are:
- To compare the effectiveness of treatments on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia.
- To determinate the influence of clinical and radiographical characteristics in pain improvement.
Participants will wear the treatment for 3 months . Researchers will compare polypropylene and EVA insoles and Fixtoe Device® to see if a foot pain improvement is achieved.
Detailed description
Type of Study: Randomised Clinical Trial.
Aim: To compare the effect of orthopedic treatment on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia.
Study Protocol Description:
Prior to the start of the study, a calculation of the sample size will be made using the GRANMO Sample Size Calculator, version .12 April 2012, with an error of 5%, assuming a confidence level of 95% and values of ß that establish an analysis power of 80%.
The study population will be randomly divided into two treatment groups, which, in turn, will be subdivided into two groups. Said randomization will be carried out using an online tool (www.randomization.com).
Treatment groups are:
- Group A: Treatment by custom insoles made of 4.5mm polypropylene, balanced in inversion 0-4º, MLA of the patient, 4mm-heel rise and metatarsal dome.
- Group A1: Treatment from the date of diagnosis until the start of insoles use (3 weeks) using the Fix-Toe® device.
- Group A2: Without orthopedic treatment from the date of diagnosis until the start of insoles use (3 weeks).
- Group B: Treatment by custom insoles made of 45º shore A E.V.A with the patient's MLA, 4mm- heel rise and metatarsal dome.
- Group B1: Treatment from the date of diagnosis until the start of insoles use (3 weeks) using the Fix-Toe® device.
- Group B2: Without orthopedic treatment from the date of diagnosis until the start of insoles use (3 weeks).
Visits protocol is as follows:
- Day 1: inclusion, clinical and radiographical evaluation. Pain questionnaires fulfillment.Treatment group allocation.
- Day 2 (3 weeks after Day 1): Pain questionnaires fulfillment. Starts insoles treatment.
- Day 3 (6 weeks after Day 2): Pain questionnaires fulfillment (telephone).
- Day 4 (6 weeks after Day 3): Pain questionnaires fulfillment. Clinical evaluation. End of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Groups Open Randomised Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| EVA plantar orthosis | Active comparator | Device: EVA plantar orthosisTreatment consisting of a personalized plantar orthosis fabricated in 45º shore A hardness Ethyl Vinyl Acetate (EVA), which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch. |
| Polypropylene plantar orthosis | Active comparator | Device: Polypropylene plantar orthosisTreatment consisting of a personalized plantar orthosis fabricated in 4mm polypropylene, which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.Orthosis fabricated following the inverted orthotic technique. |
| Fixtoe device | Active comparator | Device: EVA plantar orthosis, Device: Polypropylene plantar orthosis, Device: Fixtoe deviceFixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mechanical pain in the 2nd or 3rd metatarsophalangeal joint (MTPJ)
- Positive Laschman's drawer test in 2nd or 3rd MTPJ. (CITA)
- Physical exploration revealing pain upon the palpation in plantar plate ( when cranial-caudal pressure was directly applied in the plantar aspect of the 2nd or 3rd MTPJ). (CITA)
- Availability of dorsal-plantar and lateral wheightbearing radiography of the affected foot.
Key exclusion criteria (10 listed)
- Subjects with at least one of the following were excluded.
- Deformity of the 2nr or 3rd metatarsal head (MTH) (Freiberg's disease)
- Morton's neuroma and/or neuritic symptomatlogy y referred.
- Rigid claw or hammer toe (positive Kelikian test) whithin radiographic dislocation of 2nd or 3rd MTPJ. (CITA)
- Dermatological lesión plantar to 2nd or 3rd MTPJ (intractable plantar keratosis (IPK), foot ulcer, plantar wart, etc.)
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 |
|---|---|---|
| EVA plantar orthosisTreatment consisting of a personalized plantar orthosis fabricated in 45º shore A hardness Ethyl Vinyl Acetate (EVA), which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch. | Device | EVA plantar orthosis, Fixtoe device |
| Polypropylene plantar orthosisTreatment consisting of a personalized plantar orthosis fabricated in 4mm polypropylene, which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.Orthosis fabricated following the inverted orthotic technique. | Device | Fixtoe device, Polypropylene plantar orthosis |
| Fixtoe deviceFixtoe Device, simulating the metatarsophalangeal stabilization tape technique is worn for one month, prior to definitive treatment consisting of a personalized plantar orthosis. | Device | Fixtoe device |
Primary outcome
Foot Pain
Time frame: Up to 20 weeks.
Foot Pain measured using a 11-point VAS score. 0 is the lower (better) value and 10 is the higher (worst) value.
Foot Pain and Disability
Time frame: Up to 20 weeks.
Measured using the Foot Function Index (FFI-Sp) questionnaire (Spanish version). Higher values mean worse outcome and lower values mean better outcome.
35 secondary outcomes
Demographic data: Age.
Time frame: Day 1.
Demographic data: Gender
Time frame: Day 1.
Demographic data: Wheight
Time frame: Day 1.
Demographic data: Height
Time frame: Day 1.
Demographic data: Body Mass Index (BMI)
Time frame: Day 1.
Demographic data: Adherence to treatment
Time frame: Day 2, Day 3, Day 4.
Demographic data: Time with symptoms.
Time frame: Day 1.
Foot clinical evaluation data: Toes deformity
Time frame: Day 1.
Foot clinical evaluation data: Paper pull-out test
Time frame: Day 1, Day 2.
Foot clinical evaluation data: 1st metatarsophalangeal joint range of movement
Time frame: Day 1, Day 4
Foot clinical evaluation data: Medial column of the foot stiffness
Time frame: Day 1.
Foot clinical evaluation data: Functional Hallux Limitus
Time frame: Day 1.
Foot clinical evaluation data: First ray mobility
Time frame: Day 1.
Foot clinical evaluation data: Lunge test
Time frame: Day 1.
Foot clinical evaluation data: Arch index
Time frame: Day 1, Day 4.
Foot clinical evaluation data: Navicular Drop Test
Time frame: Day 1, Day 4.
Foot clinical evaluation data: Calcaneus relaxed standing position.
Time frame: Day 1, Day 4.
Foot clinical evaluation data: Subtalar joint axis orientation
Time frame: Day 1.
Radiographical data: HAV angle
Time frame: Day 1.
Radiographical data: 1st metatarsophalangeal joint osteoarthritis
Time frame: Day 1.
Metatarsal formula
Time frame: Day 1.
Radiographical data: 2nd metatarsophalangeal joint angle
Time frame: Day 1.
Radiographical data: 3rd metatarsophalangeal joint angle
Time frame: Day 1.
Radiographical data: M1-M2 intermetatarsal angle
Time frame: Day 1.
Radiographical data: 2nd- 3rd metatarsophalangeal joint impingement
Time frame: Day 1.
Radiographical data: 2nd - 3rd metatatsophalangeal joint radiolucency.
Time frame: Day 1.
Radiographical data: Metatarsus primus elevatus
Time frame: Day 1.
Radiographical data: 1st cuneiform - 2nd metatarsal gap
Time frame: Day 1.
Radiographical data: talar coverage angle
Time frame: Day 1.
Radiographical data: 1st cuneiform - 5th metatarsal distance
Time frame: Day 1.
Radiographical data: Meary's line
Time frame: Day 1.
Foot orthosis data: Metatarsal dome location in relation to central metatarsal heads
Time frame: Day 4.
Foot orthosis data: Metatarsal dome location in relation to 1st metatarsal head
Time frame: Day 4.
Foot orthosis data: Stability
Time frame: Day 4.
Foot orthosis data: Orthotic deformity test
Time frame: Day 4.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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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. This study is not recruiting at the moment.
Ángel M Orejana-García, PhD study director
Complutense University Madrid
Raúl J Molines-Barroso, PhD study director
Complutense University Madrid
José Luis Lázaro-Martínez, PhD study director
Complutense University Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVA plantar orthosis, Polypropylene plantar orthosis and Fixtoe device in people with Metatarsalgia and Treatment, run by Universidad Complutense de Madrid at 1 site in Spain.
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 10 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: finished, as of the sponsor's last update on 6 Feb 2023. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Foot Pain (time frame: Up to 20 weeks.). 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 6 Feb 2023.