Chronic WoundsVALRESCICNCT05491291
Chronic Wound Care of Lower Limb in M@diCICAT Center at CHU de Martinique
A study testing Patients with chronic wound of the lower limbs in people with Chronic Wounds, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
Chronic wound of lower limb. In developed countries, the prevalence of chronic wounds is linked to the ageing of the population and the increase in chronic diseases such as diabetes, obesity and cardiovascular disease. Consequence: amputations of lower limb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- Patients with chronic wound of the lower limbs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMartinique
- Study dates
- Nov 2022to Aug 2024
- 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
- Patients with at least one chronic wound of the lower limbs admitted to the M@diCICAT® healing centre.
- Patients agreeing to participate in the study
- Patients affiliated to a social security scheme
Who cannot join
- Patients with critical ischemia of the lower limb concerned
- Patients under legal protection measures (guardianship, curatorship, safeguard of justice) and persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
Martinique1 site
CHU de Martinique
Fort-de-France, 97261
Maria CANO SANCHEZ, RN, 0596553545 ext. +596, maria.canosanchez@chu-martinique.fr
About this study
Official title: Cross-cultural and Psychometric Validation of the RESVECH 2.0 Scale for the Assessment of Chronic Wounds in the French West Indies.
Chronic wound of lower limb. In developed countries, the prevalence of chronic wounds is linked to the ageing of the population and the increase in chronic diseases such as diabetes, obesity and cardiovascular disease. Consequence: amputations of lower limb. The prevalence of chronic wounds is also variable across the globe. In addition, chronic wounds are associated with psychosocial problems such as poor quality of life, loss of professional activity and progressive de-socialization of patients. To improve the quality of care we need in french wound assessment tools validated scientifically like the RESVECH 2.0 scale, validated in the Spanish language.
Read the detailed description
The VALRESCIC study aims to perform a cross-cultural and psychometric validation of the RESVECH 2.0 scale in order to be able to use it for monitoring wounds in both hospital and primary care settings in the French West Indies.
The RESVECH 2.0 scale is a heterogeneous scale to monitor the evolution of a chronic wound. This scale was created in 2010 and consists of 6 items with response modalities ranging from 5 to 14. The interpretation of the scale parameters may differ depending on the cultural context. The RESVECH 2.0 scale has been validated in the Spanish language (in Spain and Colombia) to assess the progress towards healing of pressure ulcers and chronic wounds of the lower limbs.
For the cross-cultural evaluation we will follow Beaton's methodology, which includes: translation, synthesis, retro-translation, expert committee review and pre-testing. For the psychometric validation, the following parameters will be measured: Feasibility and acceptability, validity, reliability, and sensitivity to change.
- Conditions
- Chronic Wounds
- Being tested
- Patients with chronic wound of the lower limbs
- Keywords
- Chronic wounds, RESVECH 2.0, Wound assesment tool, cross-cultural validation,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with chronic wound of the lower limbsOther
The rating scale will be passed at three different times, day 1, day 15 and day 75.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic wound of the lower limbs | Other | Passing of the scale when the patient will come at the hospital for his routine health care visit in M@diCICAT center Receives: Other: Patients with chronic wound of the lower limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cultural adaptation of the RESVECH 2.0 scale.
Validation of scale RESVECH 2.0 translation in french language depending on the cultural context in French West Indies
Measured: Before the start of recruitment
Psychometric validation of the RESVECH 2.0 scale.
Scientific validation of the french version of the scale RESVECH 2.0 in French West Indies
Measured: 15 days post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study startNov 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic WoundsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The rating scale will be passed at three different times, day 1, day 15 and day 75.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria CANO SANCHEZ, RN, Study director, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491291
- Sponsor's protocol ID
- 20_RIPH23-27
- Acronym
- VALRESCIC
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez-Del-Rio RF. Factors Associated to the Cicatrization Success of Lower-Limb Ulcer of Venous Etiology. Invest Educ Enferm. 2018 Sep;36(3). doi: 10.17533/udea.iee.v36n3e08.
PubMed 31083854Aragon-Sanchez J, Lipsky BA, Lazaro-Martinez JL. Diagnosing diabetic foot osteomyelitis: is the combination of probe-to-bone test and plain radiography sufficient for high-risk inpatients? Diabet Med. 2011 Feb;28(2):191-4. doi: 10.1111/j.1464-5491.2010.03150.x.
PubMed 21219428
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural and Psychometric Validation of the RESVECH 2.0 Scale for the Assessment of Chronic Wounds in the French West Indies.
- ClinicalTrials.gov ID
- NCT05491291
- Acronym / sponsor ID
- VALRESCIC / 20_RIPH23-27
- Conditions
- Chronic Wounds
- Keywords
- Chronic wounds, RESVECH 2.0, Wound assesment tool, cross-cultural validation,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 8 Aug 2022 (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.
Chronic wound of lower limb. In developed countries, the prevalence of chronic wounds is linked to the ageing of the population and the increase in chronic diseases such as diabetes, obesity and cardiovascular disease. Consequence: amputations of lower limb. The prevalence of chronic wounds is also variable across the globe. In addition, chronic wounds are associated with psychosocial problems such as poor quality of life, loss of professional activity and progressive de-socialization of patients. To improve the quality of care we need in french wound assessment tools validated scientifically like the RESVECH 2.0 scale, validated in the Spanish language.
Detailed description
The VALRESCIC study aims to perform a cross-cultural and psychometric validation of the RESVECH 2.0 scale in order to be able to use it for monitoring wounds in both hospital and primary care settings in the French West Indies.
The RESVECH 2.0 scale is a heterogeneous scale to monitor the evolution of a chronic wound. This scale was created in 2010 and consists of 6 items with response modalities ranging from 5 to 14. The interpretation of the scale parameters may differ depending on the cultural context. The RESVECH 2.0 scale has been validated in the Spanish language (in Spain and Colombia) to assess the progress towards healing of pressure ulcers and chronic wounds of the lower limbs.
For the cross-cultural evaluation we will follow Beaton's methodology, which includes: translation, synthesis, retro-translation, expert committee review and pre-testing. For the psychometric validation, the following parameters will be measured: Feasibility and acceptability, validity, reliability, and sensitivity to change.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The rating scale will be passed at three different times, day 1, day 15 and day 75.
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic wound of the lower limbs | Other | Other: Patients with chronic wound of the lower limbsPassing of the scale when the patient will come at the hospital for his routine health care visit in M@diCICAT center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with at least one chronic wound of the lower limbs admitted to the M@diCICAT® healing centre.
- Patients agreeing to participate in the study
- Patients affiliated to a social security scheme
Key exclusion criteria (2 listed)
- Patients with critical ischemia of the lower limb concerned
- Patients under legal protection measures (guardianship, curatorship, safeguard of justice) and persons deprived of liberty
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 |
|---|---|---|
| Patients with chronic wound of the lower limbsThe rating scale will be passed at three different times, day 1, day 15 and day 75. | Other | Patients with chronic wound of the lower limbs |
Primary outcome
Cultural adaptation of the RESVECH 2.0 scale.
Time frame: Before the start of recruitment
Validation of scale RESVECH 2.0 translation in french language depending on the cultural context in French West Indies
Psychometric validation of the RESVECH 2.0 scale.
Time frame: 15 days post inclusion
Scientific validation of the french version of the scale RESVECH 2.0 in French West Indies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Results publication: PubMed 31083854Alvarez-Del-Rio RF. Factors Associated to the Cicatrization Success of Lower-Limb Ulcer of Venous Etiology. Invest Educ Enferm. 2018 Sep;36(3). doi: 10.17533/udea.iee.v36n3e08.
- Results publication: PubMed 21219428Aragon-Sanchez J, Lipsky BA, Lazaro-Martinez JL. Diagnosing diabetic foot osteomyelitis: is the combination of probe-to-bone test and plain radiography sufficient for high-risk inpatients? Diabet Med. 2011 Feb;28(2):191-4. doi: 10.1111/j.1464-5491.2010.03150.x.
- A Coefficient of Agreement for Nominal ScalesLink provided by the sponsor.
- Validation des échelles d'évaluation en médecine physique et de réadaptation : comment apprécier correctement leurs qualités psychométriquesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Wounds
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
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.
Maria CANO SANCHEZ, RN study director
CHU de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with chronic wound of the lower limbs in people with Chronic Wounds, run by University Hospital Center of Martinique at 1 site in Martinique.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Aug 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 Martinique. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jocelyne CRASPAG, MSc (0596592698 ext. +596, jocelyne.craspag@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cultural adaptation of the RESVECH 2.0 scale. (time frame: Before the start of recruitment). 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?
On the ClinicalTrials.gov record for NCT05491291, which also lists 2 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 8 Aug 2022.