Status:
COMPLETED
VistaCare® in the Treatment of Wounds of the Lower Extremity
Lead Sponsor:
DTAMedical SAS
Conditions:
Wound Heal
Eligibility:
All Genders
18+ years
Brief Summary
Assessment of the safety and performance of the VistaCare® medical device in current medical practice in the treatment of acute and chronic lower limb wounds.
Detailed Description
The study is an open-label, prospective, multicenter, post-CE mark (European Conformity assessment indicating marketing approval in Europe) study to assess the safety and performance of the VistaCare®...
Eligibility Criteria
Inclusion
- male or female consenting and able patients aged 18 or more affiliated to social security
- presenting with acute or chronic traumatic or surgical lower limb wounds (excluding tumoral excision)
- presenting with no intercurrent pathology which in the opinion of the investigator may interfere with the capacity for wound healing
- patients whose wound is compatible in terms of location with VistaCare treatment
- patient whose wound has a minimal surface of 10 cm2
- patient whose wound does not need surgical Peterson after inclusion (if needed should be performed prior to inclusion)
Exclusion
- Female patients pregnant, lactating, or of childbearing age and not using adequate contraception (pregnancy test mandatory)
- patients incapable of making an informed decision about participation
- patients presenting a condition that interferes with adequate wound healing capacity (uncontrolled diabetes, heavy smokers, auto-immune disease)
- concurrent treatment or treatment within one month prior to inclusion with local or systemic corticosteroids, immunosuppresseurs, chemotherapy or radiotherapy
- wound location incompatible with VistaCare
- general infection signs at the time of inclusion (fever, lymphangitis, pus ...)
- patients presenting with important uncontrolled hemorrhage at the time of inclusion
- patients previously recruited into this trial or any other trial within 1 month, or currently in the exclusion timeframe of another trial
- patients with a wound surface less than 10 cm2
- patient with a would previously treated with hyperbaric chamber
- legally incapacitated, under guardianship or psychiatric patients
- emergency condition prohibiting adequate patient consent prior to inclusion
Key Trial Info
Start Date :
February 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03790202
Start Date
February 18 2019
End Date
February 1 2021
Last Update
February 2 2021
Active Locations (5)
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1
CHU Henri Mondor
Créteil, France, 94010
2
Hôpital La Timone
Marseille, France, 13005
3
Hôpital de la Conception
Marseille, France, 13385
4
Hôpital La Timone
Marseille, France, 13385