Venous Stasis UlcersNCT01050023
Provant Therapy of Venous Stasis Ulcer Trial
A study testing Provant Device (Wound Therapy System) and Provant Device - Inactive in people with Venous Stasis Ulcers, run by Southern California Institute for Research and Education at 2 sites in United States.
Trial summary
This pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to improper functioning of valves in the veins, usually of the legs) will result in increased rates of healing and a larger proportion of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Stasis Ulcers
- What is being tested?
- Provant Device (Wound Therapy System) and Provant Device - Inactive
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Nov 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ulcer size between 1.0 and 16.0 cm2 at the time of randomization - measurements to be taken after sharp debridement if this is performed at the screening visit. Wounds must be free of necrotic tissue and fibrin slough after debridement with at least 90% of the surface covered with granulation tissue.
- Target ulcer must be present for at least 6 weeks prior to randomization. Other ulcers close to the study ulcer are allowable and may be any size but should be greater than 2cm away from the study ulcer; no more than 4 ulcers total on the target limb are allowed.
- A duplex ultrasound study documenting venous disease must be performed within on year of study entry. The ultrasound exam should document either chronic occlusion of the target limb popliteal, femoral, or iliac veins or the vena cava, or occlusion in the greater or lesser saphenous veins, or reflux in either the deep, saphenous, or perforating veins.
Who cannot join
- No ulcer on the target limb including the study ulcer may be deep enough to expose structures deep to the adipose lay of skin such as muscle, fascia, tendon, joint, or bone. The presence of sinus tracts that have not been sufficiently marsupialized such that the wound depth can be assessed by gross visual inspection is similarly exclusion.
- At the Screening or Randomization Visits, the presence of significant periwound cellulitis or the need to administer systemic antibiotics. system antibiotic therapy for any indication within 10 days of screening is an exclusion.
- Baseline arterial studies obtained within one year of screening or at the screening visit must show either an ankle-brachial index of the affected limb greater or equal to 0.75 based on the higher of the two pedal arteries systolic pressure measured with Doppler ultrasound compared to the ipsilateral brachial artery systolic pressure determined with Doppler ultrasound.
- Any major surgery or trauma affecting the target limb such as tibial fracture, knee arthroplasty, endovascular or open arterial or venous surgery or femoral stenting within 180 days of randomization.
- Participation in any clinical trial involving therapy for wound healing within 30 days of randomization.
- Concurrent administration of systemic agents that influence wound healing such as prednisone or dexamethasone in any quantity, cytotoxic chemotherapy agents, or immunosuppressive therapy.
Show all 24Show fewer
- Previous ionizing radiation therapy at any dose near the wound bed (within 5 cm).
- A history of cancer in the target limb except for previous skin cancer treated in the target limb provided that a biopsy of the target wound is obtained within 90 days of randomization that confirms the absence of neoplasia.
- Severe renal failure - serum creatinine greater than 2.5 or subject on hemodialysis.
- Severe hepatic insufficiency: known cirrhosis, any degree of ascites, serum transamines more than three times the upper limit of normal.
- Known allergy or intolerance to cadexomeric iodine or latex free Profore bandages.
- The presence of 1) implanted pacemaker, automatic defibrillator, neurostimulator, bone stimulators, cochlear implants, or other devices with metal leads; 2) implanted or programmable pumps or intravenous or intrathecal drug delivery; 3) metal implant within 25 cm of area of treatment.
- Pregnancy. Women of childbearing potential must agree to use adequate contraception.
- Live expectancy of last than one year.
- Uncompensated or uncontrolled right heart failure with associated edema.
- Inability to walk independently (adaptive devices such as walkers or canes are allowed).
- BMI greater than 50.
- Severe anemia, hemoglobin less than 8.5
- Poorly controlled diabetes, A1cHgb greater than 12
- Severe hypoalbuminemia, serum albumen less than 2.6.
- Active local or systemic malignancy such as lung cancer or leukemia
- Severe hypertension - systolic bp greater than 180 or diastolic bp greater than 100
- Severe hypoxemia - chronic oxygen or ventilator therapy.
- HIV infection unless on retroviral therapy and viral load undetectable by PCR.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Long Beach Healthcare System
Long Beach, California, 90822-5201
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
About this study
This pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to improper functioning of valves in the veins, usually of the legs) will result in increased rates of healing and a larger proportion of completely healed wounds after 12 weeks of therapy compared to wounds treated identically using a Provant device that is not activated to emit radiofrequency.
- Conditions
- Venous Stasis Ulcers
- Being tested
- Provant Device (Wound Therapy System), Provant Device - Inactive
- Keywords
- venous stasis ulcer, wound healing, Provant Wound Closure System, radiofrequency, Provant, pain relief
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provant Device (Wound Therapy System)Device
Twice daily application of the active Provant device to the wound for twelve (12) weeks.
Provant Device - InactiveDevice
Twice daily application of the inactive Provant device to the wound for twelve (12) weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Active Treatment | Experimental | Provant device activated to emit RF energy Receives: Device: Provant Device (Wound Therapy System) |
| 2 - Inactive Treatment | Sham comparator | Provant device not activated to emit RF energy Receives: Device: Provant Device - Inactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of wound closure (measured as change in surface area - mm2/day)
Measured: during and after 12 weeks of therapy
Secondary outcomes (1)
Proportion of wounds achieving complete healing
Measured: afer 12 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Stasis UlcersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Regenesis Biomedical, Inc.
- Investigators
- Ian Gordon, M.D., Ph.D., Principal investigator, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050023
- Sponsor's protocol ID
- #965
- Status last verified
- Jul 2011
- First submitted
- 13 Jan 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provant Therapy of Venous Stasis Ulcer Trial
- ClinicalTrials.gov ID
- NCT01050023
- Acronym / sponsor ID
- #965
- Conditions
- Venous Stasis Ulcers
- Keywords
- venous stasis ulcer, wound healing, Provant Wound Closure System, radiofrequency, Provant, pain relief
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Regenesis Biomedical, Inc.
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 15 Jan 2010 (estimated)
- 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 pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to improper functioning of valves in the veins, usually of the legs) will result in increased rates of healing and a larger proportion of completely healed wounds after 12 weeks of therapy compared to wounds treated identically using a Provant device that is not activated to emit radiofrequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Active Treatment | Experimental | Device: Provant Device (Wound Therapy System)Provant device activated to emit RF energy |
| 2 - Inactive Treatment | Sham comparator | Device: Provant Device - InactiveProvant device not activated to emit RF energy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ulcer size between 1.0 and 16.0 cm2 at the time of randomization - measurements to be taken after sharp debridement if this is performed at the screening visit. Wounds must be free of necrotic tissue and fibrin slough after debridement with at least 90% of the surface covered with granulation tissue.
- Target ulcer must be present for at least 6 weeks prior to randomization. Other ulcers close to the study ulcer are allowable and may be any size but should be greater than 2cm away from the study ulcer; no more than 4 ulcers total on the target limb are allowed.
- A duplex ultrasound study documenting venous disease must be performed within on year of study entry. The ultrasound exam should document either chronic occlusion of the target limb popliteal, femoral, or iliac veins or the vena cava, or occlusion in the greater or lesser saphenous veins, or reflux in either the deep, saphenous, or perforating veins.
Key exclusion criteria (24 listed)
- No ulcer on the target limb including the study ulcer may be deep enough to expose structures deep to the adipose lay of skin such as muscle, fascia, tendon, joint, or bone. The presence of sinus tracts that have not been sufficiently marsupialized such that the wound depth can be assessed by gross visual inspection is similarly exclusion.
- At the Screening or Randomization Visits, the presence of significant periwound cellulitis or the need to administer systemic antibiotics. system antibiotic therapy for any indication within 10 days of screening is an exclusion.
- Baseline arterial studies obtained within one year of screening or at the screening visit must show either an ankle-brachial index of the affected limb greater or equal to 0.75 based on the higher of the two pedal arteries systolic pressure measured with Doppler ultrasound compared to the ipsilateral brachial artery systolic pressure determined with Doppler ultrasound.
- Any major surgery or trauma affecting the target limb such as tibial fracture, knee arthroplasty, endovascular or open arterial or venous surgery or femoral stenting within 180 days of randomization.
- Participation in any clinical trial involving therapy for wound healing within 30 days of randomization.
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 |
|---|---|---|
| Provant Device (Wound Therapy System)Twice daily application of the active Provant device to the wound for twelve (12) weeks. | Device | 1 - Active Treatment |
| Provant Device - InactiveTwice daily application of the inactive Provant device to the wound for twelve (12) weeks. | Device | 2 - Inactive Treatment |
Primary outcome
Rates of wound closure (measured as change in surface area - mm2/day)
Time frame: during and after 12 weeks of therapy
1 secondary outcome
Proportion of wounds achieving complete healing
Time frame: afer 12 weeks of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
Related trials for Venous Stasis Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
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.
Ian Gordon, M.D., Ph.D. principal investigator
VA Long Beach Healthcare System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provant Device (Wound Therapy System) and Provant Device - Inactive in people with Venous Stasis Ulcers, run by Southern California Institute for Research and Education at 2 sites 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 3 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Rates of wound closure (measured as change in surface area - mm2/day) (time frame: during and after 12 weeks of therapy). 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 20 Jul 2011.