Carrying a Chronic Wound Clinical Trial
— DOMOPLAIESOfficial title:
Medico-economic Evaluation of the DOMOPLAIES Project by the CICAT-LR Network
Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds compared with the usual care(with or without CICAT-LR Network).
| Status | Completed |
| Enrollment | 193 |
| Est. completion date | March 2016 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Being adult - Taken up residence on the Languedoc-Roussillon - Patient carrying a wound with healing or improvement objective (wound closure or the appearance of 40% of granulation) - Informed consent signed, - Patient member of the Security Social - Patient having a visiting nurse. Exclusion Criteria: - Patient in vital or functional emergency situation during the first call or during the consultation - Tumoral wound - dialysis patient - Arteritis of stage 4 and not revascularizable - Absence of regular doctor and visiting nurse - patient refusal - Refusal of one of the health professionals participating in the pathology care - Anybody incapable to communicate and to answer the questions - Pregnant or nursing woman - Subject deprived of freedom by court or administrative order - Major subject protected by the law - For the patients in telemedicine: refusal of the collaboration agreement |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Wound healing Department | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of healed chronic wounds during a telemedicine care | Rate of healed chronic wounds during a telemedicine care versus during a usual medical care | Six months after inclusion | No |
| Primary | Rate of healed chronic wounds during a usual medical care | Rate of healed chronic wounds during a telemedicine care versus during a usual medical care | Six months after inclusion | No |
| Secondary | Result to the questionnaire on the quality of life: EQ-5D | Compare the quality of life of patients with chronic wounds during a telemedicine coverage versus during a usual medical care, thanks to the EQ-5D quality life scale. | Six months after inclusion | No |
| Secondary | A measure of the costs of the management of the disease | A measure of the costs of the management of the disease (consumer care, hospitalization, transport ...) | Seven months after the inclusion of the last patient | No |
| Secondary | A measure of the costs of the intervention assessed | A measure of the costs of the intervention assessed (investment, maintenance, training ...). | Seven months after the inclusion of the last patient | No |
| Secondary | The total healing time | Six months after inclusion | No | |
| Secondary | The decrease in centimeters of the wound surface to 6 months | Six months after inclusion | No | |
| Secondary | The response time between making an appointment and support | Six months after inclusion | No | |
| Secondary | The mortality rate within 6 months | Six months after inclusion | No |