Ulcer, Leg Clinical Trial
— ULCERALGIQUEOfficial title:
Interest of Skin Graft Pellets in the Management of Ulcers Algic
NCT number | NCT02904707 |
Other study ID # | ULCERALGIQUE |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | May 2015 |
Verified date | September 2016 |
Source | Groupe Hospitalier Paris Saint Joseph |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Patients minors - Patients with dementia |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Paris Saint Joseph | Paris | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Paris Saint Joseph |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Day -1, Day 1 and Day 7 | |
Secondary | 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. | Day -1, Day 1 and Day 7 |
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