Interest of Skin Graft Pellets in the Management of Ulcers Algic

NCT02904707 | Completed DMC

• 1 other identifier: ULCERALGIQUE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ulcer, Leg; Ulcer Algic

Keywords

Skin Graft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of change of the impact of painful ulcers usin EQ-5D Questionary

  Day -1, Day 1 and Day 7

Study Arms (1)

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.

Other: Questionary EQ-5D

Interventions

Questionary EQ-5D OTHER

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.

Questionary EQ-5D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with one or more ulcers of venous, arterial or microcirculatory origin for more than four to six weeks

You may qualify if:

• 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

You may not qualify if:

• Patients minors
• Patients with dementia

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Isabelle LAZARETH, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 19, 2016
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 14, 2018

Record last verified: 2016-09

Locations

FR (1)