Ulcer, LegULCERALGIQUENCT02904707
Interest of Skin Graft Pellets in the Management of Ulcers Algic
An observational study of Ulcer, Leg and Ulcer Algic, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Leg ulcers (UDJ) is defined as a chronic skin wound, lasting for more than 4 to 6 weeks, between the knee and foot, and with no tendency to spontaneous healing. In 2002, the prevalence of leg ulcers is estimated between 0.5% and 1% of the general population and 3% in subjects over 65 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer, Leg, Ulcer Algic
- What is being tested?
- Questionary EQ-5D
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to May 2015
- Phase
- Observational
- 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
Study population: Patient with one or more ulcers of venous, arterial or microcirculatory origin for more than four to six weeks
Who may be able to join
- Inpatient consecutively
- over 18 years old, man, woman,
- having one or more ulcers of venous, arterial or microcirculatory
- for more than four to six weeks
- answering yes to the question: is it painful ulcer?
- consultant in vascular medicine department of St. Joseph hospital in February the month of April 2015
Who cannot join
- Patients minors
- Patients with dementia
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Leg ulcers (UDJ) is defined as a chronic skin wound, lasting for more than 4 to 6 weeks, between the knee and foot, and with no tendency to spontaneous healing.
In 2002, the prevalence of leg ulcers is estimated between 0.5% and 1% of the general population and 3% in subjects over 65 years.
Read more
The sex ratio is generally 3 females to 1 male. It is in most cases a complication of vascular disease, usually venous (70 to 90%), then blood (5-15%), mixed (5-10%) and microcirculatory.
In three quarter of cases, the UDJ is a chronic painful wound to the social repercussions (sleep disorders, eating, work stoppages) and major economic (individual and collective costs of absorptions).
The treatment of a chronic wound uses validated techniques for several years as the skin graft in tablets, associated with the etiological treatment.
The latest recommendations HAS implemented to date from 2006 and concerns the management of leg ulcers predominantly venous.
Few articles in the literature address the possibility of an analgesic effect of the transplant pellets in the treatment of chronic ulcers algic.
In 2008, a Swedish article, evaluated pain before and after skin grafting in carriers of leg ulcer patients and feet and showed that there was a reduction in pain post transplant.
We propose to evaluate the analgesic effect of the skin graft in pellet on a patient population having one or more Algic ulcers.
Read the detailed description
Development of the study:
An information note and the non-opposition of the patient will be collected on the first day of hospitalization. The written and signed consent will be recorded in the patient record.
Clinical data will be collected during hospitalization of the patient, respecting his anonymity only initials and year of birth will be made in terms of data that distinguish patients.
The EQ-5D questionary will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives.
Finally, a pain assessment questionary by NE (Numeric Evaluation) before and after the skin graft pellet, will be filled by a caregiver during an interview with each patient.
Methodology :
Design: open, prospective, single centric (Vascular Medicine Department), Interventional.
The data to be collected are:
The age, sex, weight, height Length of hospitalization, The type of ulcer, the size of the ulcer disease duration of current or ulcers, duration of ulcer disease The graft antecedent, number of grafts placed in the registry, the date of completion of the graft, The evaluation of pain before and after the completion of the graft on EN, The impact of pain on patient's quality of sleep, the type of pain experienced by patients in terms of their ulcers
The type and number of analgesics taken by patients:
- Antiepileptic therapy (pregabapentine, gabapentin)
- Analgesic treatment to alleviate I (paracetamol), to overcome II (codeine paracetamol, Lamaline, tramadol, nefopam, Ixprim), and compensate III (morphine, opiates).
- Conditions
- Ulcer, Leg, Ulcer Algic
- Being tested
- Questionary EQ-5D
- Keywords
- Skin Graft
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionary EQ-5DOther
In addition to the pain questionary that is filled filled as usual, the EQ-5D questionary will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives.
| Study group | Role | What they receive |
|---|---|---|
| Questionary EQ-5D | The EQ-5D questionary will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives.
Finally, a pain assessment questionnaire by Numeric Evaluation Scale before and after the skin graft pellet, will be filled by a caregiver during an interview with each patient. Receives: Other: Questionary EQ-5D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of pain by Numeric Evaluation Scale
A pain assessment questionnaire by Numeric Evaluation Scale NE (pain rating scale measuring pain intensity from 0 to 10) before and after the skin graft pellet, will be filled by a caregiver during an interview with each patient
Measured: Day -1, Day 1 and Day 7
Secondary outcomes (1)
Assessment of change of the impact of painful ulcers usin EQ-5D Questionary
The EQ-5D questionnaire will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives.
Measured: Day -1, Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer, LegStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle LAZARETH, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904707
- Sponsor's protocol ID
- ULCERALGIQUE
- Acronym
- ULCERALGIQUE
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Skin Graft Pellets in the Management of Ulcers Algic
- ClinicalTrials.gov ID
- NCT02904707
- Acronym / sponsor ID
- ULCERALGIQUE / ULCERALGIQUE
- Conditions
- Ulcer, Leg, Ulcer Algic
- Keywords
- Skin Graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
Leg ulcers (UDJ) is defined as a chronic skin wound, lasting for more than 4 to 6 weeks, between the knee and foot, and with no tendency to spontaneous healing.
In 2002, the prevalence of leg ulcers is estimated between 0.5% and 1% of the general population and 3% in subjects over 65 years.
The sex ratio is generally 3 females to 1 male. It is in most cases a complication of vascular disease, usually venous (70 to 90%), then blood (5-15%), mixed (5-10%) and microcirculatory.
In three quarter of cases, the UDJ is a chronic painful wound to the social repercussions (sleep disorders, eating, work stoppages) and major economic (individual and collective costs of absorptions).
The treatment of a chronic wound uses validated techniques for several years as the skin graft in tablets, associated with the etiological treatment.
The latest recommendations HAS implemented to date from 2006 and concerns the management of leg ulcers predominantly venous.
Few articles in the literature address the possibility of an analgesic effect of the transplant pellets in the treatment of chronic ulcers algic.
In 2008, a Swedish article, evaluated pain before and after skin grafting in carriers of leg ulcer patients and feet and showed that there was a reduction in pain post transplant.
We propose to evaluate the analgesic effect of the skin graft in pellet on a patient population having one or more Algic ulcers.
Detailed description
Development of the study:
An information note and the non-opposition of the patient will be collected on the first day of hospitalization. The written and signed consent will be recorded in the patient record.
Clinical data will be collected during hospitalization of the patient, respecting his anonymity only initials and year of birth will be made in terms of data that distinguish patients.
The EQ-5D questionary will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives.
Finally, a pain assessment questionary by NE (Numeric Evaluation) before and after the skin graft pellet, will be filled by a caregiver during an interview with each patient.
Methodology :
Design: open, prospective, single centric (Vascular Medicine Department), Interventional.
The data to be collected are:
The age, sex, weight, height Length of hospitalization, The type of ulcer, the size of the ulcer disease duration of current or ulcers, duration of ulcer disease The graft antecedent, number of grafts placed in the registry, the date of completion of the graft, The evaluation of pain before and after the completion of the graft on EN, The impact of pain on patient's quality of sleep, the type of pain experienced by patients in terms of their ulcers
The type and number of analgesics taken by patients:
- Antiepileptic therapy (pregabapentine, gabapentin)
- Analgesic treatment to alleviate I (paracetamol), to overcome II (codeine paracetamol, Lamaline, tramadol, nefopam, Ixprim), and compensate III (morphine, opiates).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionary EQ-5D | – | Other: Questionary EQ-5DThe EQ-5D questionary will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives. Finally, a pain assessment questionnaire by Numeric Evaluation Scale before and after the skin graft pellet, will be filled by a caregiver during an interview with each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with one or more ulcers of venous, arterial or microcirculatory origin for more than four to six weeks
Key inclusion criteria (6 listed)
- Inpatient consecutively
- over 18 years old, man, woman,
- having one or more ulcers of venous, arterial or microcirculatory
- for more than four to six weeks
- answering yes to the question: is it painful ulcer?
Key exclusion criteria (2 listed)
- Patients minors
- Patients with dementia
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 |
|---|---|---|
| Questionary EQ-5DIn addition to the pain questionary that is filled filled as usual, the EQ-5D questionary will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives. | Other | Questionary EQ-5D |
Primary outcome
Assessment of change of pain by Numeric Evaluation Scale
Time frame: Day -1, Day 1 and Day 7
A pain assessment questionnaire by Numeric Evaluation Scale NE (pain rating scale measuring pain intensity from 0 to 10) before and after the skin graft pellet, will be filled by a caregiver during an interview with each patient
1 secondary outcome
Assessment of change of the impact of painful ulcers usin EQ-5D Questionary
Time frame: Day -1, Day 1 and Day 7
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 14 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Isabelle LAZARETH, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcer, Leg and Ulcer Algic, run by Fondation Hôpital Saint-Joseph 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 6 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: finished, as of the sponsor's last update on 14 Aug 2018. 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 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?
Assessment of change of pain by Numeric Evaluation Scale (time frame: Day -1, Day 1 and Day 7). 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 14 Aug 2018.