Venous InsufficiencyNCT01549860
Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
A study testing MIST Therapy in people with Venous Insufficiency and Venous Reflux, run by Celleration, Inc. at 1 site in United States.
Trial summary
This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care (SOC) alone in the treatment of lower extremity… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer
- What is being tested?
- MIST Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower extremity full thickness venous ulcer of > 30 days duration
- Subject's wound must be between 4 cm² and 50 cm² at screening
- Documented ABI that is between 0.8 and 1.2 on the study limb or transcutaneous partial pressure oxygen (TcpO2) > 40 mmHG; or a toe pressure > 40 mmHG; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at time of screening
- Biopsy for wounds > 6 months duration
- Documented index wound etiology of venous stasis with reflux and /or incompetent valves
Who cannot join
- Index ulcer wound that is less than 1 cm in distance from another ulcer wound
- > 5 ulcers on the index leg
- Index ulcer wound has exposed tendons, ligaments, muscle, or bone
- Index ulcer wound presents with clinical signs of acute infection, suspected or known
- Subjects with evidence of osteomyelitis or cellulitis or gangrene in the study limb
- Subjects with amputation above a Trans Metatarsal Amputation (TMA) in the study limb
Show all 21Show fewer
- Subjects with active malignancy on the study limb except non-melanoma skin cancer
- Index ulcer that is of arterial disease etiology
- Index ulcer of other primary etiology (ie. vasculitis, arterial, pyoderma)
- Subjects with planned vascular surgery, angioplasty or thrombolysis procedures within the study treatment phase
- Subjects with planned surgical procedure during the study treatment phase for the index wound including skin flap or skin graft
- Subjects within 6 weeks postoperatively of a vascular o skin graft procedure.
- Subject has had prior skin replacement, negative pressure therapy, or traditional ultrasound therapy applied to the index wound in the 14 days prior to screening
- Subject has had ultrasound treatment (including MIST Therapy) of the index wound.
- Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within 14 days of screening date.
- Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- Female subjects that are pregnant or refuse to utilize adequate contraceptive methods and are of childbearing age during the trial.
- Subject has one or more medical condition(s), uncontrolled diabetes (i.e. HbA1c > 12), renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the subject an inappropriate study candidate
- Subject's wound would require ultrasound near an electronic implant or prosthesis
- Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements
- Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IN-BALANCE VLU Inflammation, Bacteria, & Angiogenesis Effects in Launching Venous Leg Ulcer Healing
This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care (SOC) alone in the treatment of lower extremity venous ulcers.
Read the detailed description
The study compared the treatment effect of non-contact low frequency ultrasound in addition to standard of care versus standard of care alone in healing chronic venous leg ulcers in subjects who had documented venous stasis and reflux. Subjects that were screened and met the major inclusion criteria received standardized treatment of 30 to 40 mmHg compression, moist wound healing dressings, and debridement for a two week run-in period. If their study ulcer did not decreased by greater than 30% they were eligible for randomization. The primary endpoint was wound area reduction after four (4) weeks of study treatment. The study was performed at 22 study centers. The study included two sub-studies: fluid and tissue analysis and a wound recidivism registry that are ongoing.
- Conditions
- Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer
- Being tested
- MIST Therapy
- Keywords
- Venous Insufficiency, Reflux, Lower Extremity Ulcer
- Medical subject headings
- Venous Insufficiency, Leg Ulcer, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIST TherapyDevice
Non-contact low frequency ultrasound therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | 30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks |
| SOC + Mist Therapy | Experimental | 30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks. Receives: Device: MIST Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Area Mean Percent Reduction
Compare between the treatment groups percent wound area reduction at four weeks of study treatment.
H0: µMIST+SC -- µSC = 0 HA: µMIST+SC -- µSC ≠ 0 Where µ = percent reduction in wound size.
Measured: 4 weeks post baseline visit (randomization visit)
Secondary outcomes (2)
Heal Rates
Compare rate of wound closure between study arms for 12 weeks post randomization. Descriptive statistics as not a powered endpoint.
Measured: 12 weeks post randomization
Change in Pain VAS Scores
Compare VAS Pain Scores between arms at baseline and 4 weeks post randomization
Subjects indicate their pain level by drawing a mark on a 10 cm line on a visual analog scale (VAS) at randomization and 4 week post treatment visit. The left end of the line indicates "no pain" and the right end of line indicates "worst pain imaginable". VAS score is determined by using a ruler placed at 0 (left end of scale) and measuring the distance from zero to the patient's mark . The objective is to compare the change in VAS values in MIST+SC to SC alone.
H0: The average change in pain level is not different between MIST and SC HA: The average change in pain level is different between MIST and SC H0: µMIST = µSC vs HA: µMIST ≠ µSC,
Statistical Analysis. A repeated measures ANCOVA will be used to test for differences in change in VAS with an indicator variable to indicate treatment, any demographic variables which were significant in the baseline comparisons.
Measured: Baseline, 2 weeks and 4 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous InsufficiencyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celleration, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Gibbons, MD, Principal investigator, South Shore HospitalVicki Driver, DPM, Principal investigator, Providence RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549860
- Sponsor's protocol ID
- IN-BALANCE VLU
- Status last verified
- Jul 2015
- First submitted
- 7 Mar 2012
- Last updated
- 30 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN-BALANCE VLU Inflammation, Bacteria, & Angiogenesis Effects in Launching Venous Leg Ulcer Healing
- ClinicalTrials.gov ID
- NCT01549860
- Acronym / sponsor ID
- IN-BALANCE VLU
- Conditions
- Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer
- Keywords
- Venous Insufficiency, Reflux, Lower Extremity Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Celleration, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Posted 30 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care (SOC) alone in the treatment of lower extremity venous ulcers.
Detailed description
The study compared the treatment effect of non-contact low frequency ultrasound in addition to standard of care versus standard of care alone in healing chronic venous leg ulcers in subjects who had documented venous stasis and reflux. Subjects that were screened and met the major inclusion criteria received standardized treatment of 30 to 40 mmHg compression, moist wound healing dressings, and debridement for a two week run-in period. If their study ulcer did not decreased by greater than 30% they were eligible for randomization. The primary endpoint was wound area reduction after four (4) weeks of study treatment. The study was performed at 22 study centers. The study included two sub-studies: fluid and tissue analysis and a wound recidivism registry that are ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks |
| SOC + Mist Therapy | Experimental | Device: MIST Therapy30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Lower extremity full thickness venous ulcer of > 30 days duration
- Subject's wound must be between 4 cm² and 50 cm² at screening
- Documented ABI that is between 0.8 and 1.2 on the study limb or transcutaneous partial pressure oxygen (TcpO2) > 40 mmHG; or a toe pressure > 40 mmHG; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at time of screening
- Biopsy for wounds > 6 months duration
- Documented index wound etiology of venous stasis with reflux and /or incompetent valves
Key exclusion criteria (21 listed)
- Index ulcer wound that is less than 1 cm in distance from another ulcer wound
- > 5 ulcers on the index leg
- Index ulcer wound has exposed tendons, ligaments, muscle, or bone
- Index ulcer wound presents with clinical signs of acute infection, suspected or known
- Subjects with evidence of osteomyelitis or cellulitis or gangrene in the study limb
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 |
|---|---|---|
| MIST TherapyNon-contact low frequency ultrasound therapy | Device | SOC + Mist Therapy |
Primary outcome
Wound Area Mean Percent Reduction
Time frame: 4 weeks post baseline visit (randomization visit)
Compare between the treatment groups percent wound area reduction at four weeks of study treatment. H0: µMIST+SC -- µSC = 0 HA: µMIST+SC -- µSC ≠ 0 Where µ = percent reduction in wound size.
2 secondary outcomes
Heal Rates
Time frame: 12 weeks post randomization
Change in Pain VAS Scores
Time frame: Baseline, 2 weeks and 4 weeks post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gary Gibbons, MD principal investigator
South Shore Hospital
Vicki Driver, DPM principal investigator
Providence RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIST Therapy in people with Venous Insufficiency and Venous Reflux, run by Celleration, 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 21 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 30 Jul 2015. 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?
Yes. Results are posted in the registry (first posted 30 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wound Area Mean Percent Reduction (time frame: 4 weeks post baseline visit (randomization visit)). 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 30 Jul 2015.