Venous Leg UlcerHEAL INCT03544788
Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers
A study testing Cirvo™ Therapy in people with Venous Leg Ulcer, run by Radial Medical, Inc. at 1 site in United States.
Trial summary
This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Cirvo™ Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2019to 1 Feb 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between 18 and 80 years of age
- Patients (CEAP 6) who have not previously experienced a period of open ulceration exceeding 26 weeks in the affected leg
- Total venous ulcer area < 20cm2
- Duration of therapy for active venous ulcer <26 weeks prior to enrollment
- Venous insufficiency documented by venous reflex ultrasound showing mild, moderate, or severe reflux in the superficial or deep venous system
Who cannot join
- Acute DVT within the 3 months prior to enrollment
- Ulcer present for <2 weeks
- Ulcers extending with exposed fascia, tendon, or bone within the wound margins
- Lateral malleolus ulcers
- Ulcers with perforator incompetence deep to the ulceration (within 5 cm of the wound border)
- Active infection (systemic or in the affected limb)
Show all 18Show fewer
- Lower extremity gangrene
- Diabetes mellitus (Type I or II) requiring medication
- History of pulmonary vascular disease (PVD)
- History of pulmonary edema
- History of decompensated congestive heart failure (CHF)
- Open surgery or major trauma to the legs within the last six months
- History of lower limb malignancy, primary or secondary
- Acute symptomatic lower extremity thrombophlebitis
- Pregnant or breastfeeding
- Calf geometry on which Cirvo(TM) device does not appropriately fit
- Known sensitivity to any of the materials used in the Cirvo(TM) device
- Currently participating or plans to participate in in any other investigational clinical evaluation during the 12 week study period that may, in the opinion of the investigator, affect blood flow and/or venous leg ulcer
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: HEAL I (The Treatment of Venous Leg Ulcers): Evaluation of Cirvo™ Mobile Compression Device for the Treatment of Venous Leg Ulcers
This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.
- Conditions
- Venous Leg Ulcer
- Being tested
- Cirvo™ Therapy
- Keywords
- mobile compression device
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cirvo™ TherapyDevice
The Cirvo(TM) (also referred to as the Radial Medical Compression System) is a mobile wearable medical device that applies graded intermittent mechanical sequential compression for the treatment of venous leg ulcers (VLU).
| Study group | Role | What they receive |
|---|---|---|
| Cirvo™ Therapy | Experimental | Not described Receives: Device: Cirvo™ Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects fully healed at 12 weeks
Measured: 12 weeks
Secondary outcomes (2)
Percent of wound epithelialized at 12 weeks
Measured: 12 weeks
Percent of subjects fully healed at 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start30 Jun 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cirvo™ Therapy
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radial Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544788
- Sponsor's protocol ID
- RMP-002
- Acronym
- HEAL I
- Status last verified
- Sep 2019
- First submitted
- 21 May 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEAL I (The Treatment of Venous Leg Ulcers): Evaluation of Cirvo™ Mobile Compression Device for the Treatment of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT03544788
- Acronym / sponsor ID
- HEAL I / RMP-002
- Conditions
- Venous Leg Ulcer
- Keywords
- mobile compression device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Radial Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 4 Jun 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.
This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cirvo™ Therapy
| Arm | Type | Receives |
|---|---|---|
| Cirvo™ Therapy | Experimental | Device: Cirvo™ Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients between 18 and 80 years of age
- Patients (CEAP 6) who have not previously experienced a period of open ulceration exceeding 26 weeks in the affected leg
- Total venous ulcer area < 20cm2
- Duration of therapy for active venous ulcer <26 weeks prior to enrollment
- Venous insufficiency documented by venous reflex ultrasound showing mild, moderate, or severe reflux in the superficial or deep venous system
Key exclusion criteria (18 listed)
- Acute DVT within the 3 months prior to enrollment
- Ulcer present for <2 weeks
- Ulcers extending with exposed fascia, tendon, or bone within the wound margins
- Lateral malleolus ulcers
- Ulcers with perforator incompetence deep to the ulceration (within 5 cm of the wound border)
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 |
|---|---|---|
| Cirvo™ TherapyThe Cirvo(TM) (also referred to as the Radial Medical Compression System) is a mobile wearable medical device that applies graded intermittent mechanical sequential compression for the treatment of venous leg ulcers (VLU). | Device | Cirvo™ Therapy |
Primary outcome
Percent of subjects fully healed at 12 weeks
Time frame: 12 weeks
2 secondary outcomes
Percent of wound epithelialized at 12 weeks
Time frame: 12 weeks
Percent of subjects fully healed at 4 weeks
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Venous Leg Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cirvo™ Therapy in people with Venous Leg Ulcer, run by Radial Medical, Inc. at 1 site in United States.
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 5 inclusion and 18 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: withdrawn, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percent of subjects fully healed at 12 weeks (time frame: 12 weeks). 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 11 Sep 2019.