Interest of Skin Graft Pellets in the Management of Ulcers Algic
ULCERALGIQUE
ULCERALGIQUE
Sponsor study identifier
observational
50
1 country
1
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
May 2015
Actual (reported)May 2015
Actual (reported)September 1, 2016
Actual (reported)September 19, 2016
Actual (reported)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
Assessment of change of the impact of painful ulcers usin EQ-5D Questionary
Day -1, Day 1 and Day 7
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patient with one or more ulcers of venous, arterial or microcirculatory origin for more than four to six weeks
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014, France
Isabelle LAZARETH, MD
Fondation Hôpital Saint-Joseph
50 participants (actual enrollment reported by the registry).
First Submitted
September 1, 2016
First Posted
September 19, 2016
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
August 14, 2018
Record last verified: 2016-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: