Wound HealNCT03790202
VistaCare® in the Treatment of Wounds of the Lower Extremity
An observational study of Wound Heal, run by DTAMedical SAS at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- VistaCare®
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 5 sitesFrance
- Study dates
- 18 Feb 2019to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients addressed to the hospital investigators, aged 18 and more, suffering from acute or chronic lower extremity wounds
Who may be able to join
- 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)
Who cannot join
- 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 ...)
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Henri Mondor
Créteil, 94010
Hôpital La Timone
Marseille, 13005
Hôpital de la Conception
Marseille, 13385
Hôpital La Timone
Marseille, 13385
CHU de Nantes Centre des Brûlés
Nantes, 44093 Cedex 01
About this study
Official title: Open Label Assessment of VistaCare® Treatment in Current Medical Practice in Patients With Acute and Chronic Leg Wounds.
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.
Read the 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® device in the treatment of wounds. The duration of patient follow-up is up to 30 days, with intermediate visits at 3, 7, 15 and 30 days following initiation of treatment with the device.
Up to 30 patients will be recruited in the trial. Assessments will include clinical status, wound status, standardized photography, TcPO2 (trans-cutaneous oxygen pressure assessment) in a study sub-population, visual analogy scales to assess pain and comfort and adverse events monitoring.
- Conditions
- Wound Heal
- Being tested
- VistaCare®
- Keywords
- wound, VistaCare, wound healing, controlled atmosphere
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VistaCare®Device
Controlled atmosphere wound healing device
| Study group | Role | What they receive |
|---|---|---|
| single cohort of up to 30 patients | patients with acute or chronic lower limb wounds to be treated with the VistaCare® device Receives: Device: VistaCare® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the global Safety of use of the VistaCare® medical device in standard medical practice
Assessment of the global safety of VistaCare® in current medical practice in patients with acute or chronic lower limb wounds through monitoring of concurrent averse events throughout the study duration. This will be assessed through the frequency of occurrence of device-related events, throughout the patient's participation in the trial
Measured: up to 30 days
Assessment of the global Performance of the VistaCare® device in standard medical practice
Assessment of the global performance of the VistaCare® medical device as compared to its labeled performance in the approved indication (wound healing). This will be assessed through a global clinical assessment by the investigator of the wound improvement condition throughout the study visits, measured in 3 grades ranging from Aggravation (worst assessment), through Static (no improvement) to Improved (best assessment), taking into consideration the wound healing stage and general clinical condition per investigator's assessment.
Measured: up to 30 days
Secondary outcomes (6)
Assessment of time under VistaCare treatment till secondary treatment decision
Assessment of the time in days till decision to wound coverage, graft, wound dressing, or no further treatment needed and patient discharge. Duration in days from VistaCare treatment initiation to decision-making will be tabulated for each patient.
Measured: up to 15 days
Wound surface calorimetric assessment of wound status
Description of wound clinical status evolution through photography, wound measurement in mm2 and visual assessment of wound status. This measure is based on the surface in mm2 of the wound components on a standard photography, each wound potentially comprising 3 wound stages surfaces : necrotic (worst), granulation and epithelization (most favorable wound healing stage). Those stages are measured on each visit on a standardized photography of the wound and the wound stage evolution in time is assessed for each patient by an external reviewer. Wound staging for each patient will be analyzed in time throughout patient's participation and presented as graphs.
Measured: 30 days
Safety assessment of the VistaCare® treatment through monitoring of the frequency of adverse events
Safety assessment of the VistaCare® treatment through adverse events monitoring, with frequency of patients presenting with any adverse event and frequency of each adverse event type, namely non-serious unrelated or device-related event (respectively AE, ADE), serious unrelated event (SAE), serious device-related event (SADE), unanticipated device-related event (UADE), or device deficiency. Tabulation of frequencies in percentages of patient occurrence and number of events per patient will be provided.
Measured: throughout 30 days
TcPO2 assessment
In a sub-group of up to 10 patients, measure of the trans-cutaneous oxygen pressure (TcPO2) around the wound to assess status and potential correlation with wound status. This measure is expressed in mmHG and the correlation between this measure and the wound healing stage will be statistically assessed to indicate if wound healing may be correlated to the oxygen pressure measure.
Measured: up to 30 days
Quality of Life assessments
Patient visual analogy scale (VAS) assessments of pain and comfort. Those scales are each graduated from 0 (none) to 10 (maximum pain or discomfort). The evolution in times of such scores will be statistically assessed for each patient.
Measured: throughout 30 days
Duration of hospitalization
Assessment of the total duration of patient hospitalization in days.
Measured: throughout 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start18 Feb 2019
- Primary completion31 Dec 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- DTAMedical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominique Casanova, MD Pr, Principal investigator, Hôpital de la Conception, Marseille, FranceRegis Legré, MD Pr, Principal investigator, Hôpital de la Timone, Marseille, FrancePierre-Edouard Magnan, MD Pr, Principal investigator, Hôpital de la Timone, Marseille, FrancePascal Desgranges, MD Pr, Principal investigator, CHU Henri Mondor, Créteil, FranceFranck Duteille, MD Pr, Principal investigator, CHU Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790202
- Sponsor's protocol ID
- VistaCare® OPEN PMCF
- Status last verified
- Feb 2021
- First submitted
- 24 Dec 2018
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Assessment of VistaCare® Treatment in Current Medical Practice in Patients With Acute and Chronic Leg Wounds.
- ClinicalTrials.gov ID
- NCT03790202
- Acronym / sponsor ID
- VistaCare® OPEN PMCF
- Conditions
- Wound Heal
- Keywords
- wound, VistaCare, wound healing, controlled atmosphere
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- DTAMedical SASIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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® device in the treatment of wounds. The duration of patient follow-up is up to 30 days, with intermediate visits at 3, 7, 15 and 30 days following initiation of treatment with the device.
Up to 30 patients will be recruited in the trial. Assessments will include clinical status, wound status, standardized photography, TcPO2 (trans-cutaneous oxygen pressure assessment) in a study sub-population, visual analogy scales to assess pain and comfort and adverse events monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single cohort of up to 30 patients | – | Device: VistaCare®patients with acute or chronic lower limb wounds to be treated with the VistaCare® device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients addressed to the hospital investigators, aged 18 and more, suffering from acute or chronic lower extremity wounds
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VistaCare®Controlled atmosphere wound healing device | Device | single cohort of up to 30 patients |
Primary outcome
Assessment of the global Safety of use of the VistaCare® medical device in standard medical practice
Time frame: up to 30 days
Assessment of the global safety of VistaCare® in current medical practice in patients with acute or chronic lower limb wounds through monitoring of concurrent averse events throughout the study duration. This will be assessed through the frequency of occurrence of device-related events, throughout the patient's participation in the trial
Assessment of the global Performance of the VistaCare® device in standard medical practice
Time frame: up to 30 days
Assessment of the global performance of the VistaCare® medical device as compared to its labeled performance in the approved indication (wound healing). This will be assessed through a global clinical assessment by the investigator of the wound improvement condition throughout the study visits, measured in 3 grades ranging from Aggravation (worst assessment), through Static (no improvement) to Improved (best assessment), taking into consideration the wound healing stage and general clinical condition per investigator's assessment.
6 secondary outcomes
Assessment of time under VistaCare treatment till secondary treatment decision
Time frame: up to 15 days
Wound surface calorimetric assessment of wound status
Time frame: 30 days
Safety assessment of the VistaCare® treatment through monitoring of the frequency of adverse events
Time frame: throughout 30 days
TcPO2 assessment
Time frame: up to 30 days
Quality of Life assessments
Time frame: throughout 30 days
Duration of hospitalization
Time frame: throughout 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Sponsor's internet siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Wound Heal
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Recruiting
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Difficult-to-heal Wounds
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Casanova, MD Pr principal investigator
Hôpital de la Conception, Marseille, France
Regis Legré, MD Pr principal investigator
Hôpital de la Timone, Marseille, France
Pierre-Edouard Magnan, MD Pr principal investigator
Hôpital de la Timone, Marseille, France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Heal, run by DTAMedical SAS at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the global Safety of use of the VistaCare® medical device in standard medical practice (time frame: up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.