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Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers

Primary Purpose

Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MIST Therapy

About this trial

This is an interventional treatment trial for Venous Insufficiency focused on measuring Venous Insufficiency, Reflux, Lower Extremity Ulcer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

South Shore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

SOC + Mist Therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Heal Rates

Compare rate of wound closure between study arms for 12 weeks post randomization. Descriptive statistics as not a powered endpoint.

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.

Full Information

NCT ID

NCT01549860

First Posted

March 7, 2012

Last Updated

July 2, 2015

Sponsor

Celleration, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01549860

Brief Title

Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers

Official Title

IN-BALANCE VLU Inflammation, Bacteria, & Angiogenesis Effects in Launching Venous Leg Ulcer Healing

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celleration, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer

Keywords

Venous Insufficiency, Reflux, Lower Extremity Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

156 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

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

Arm Title

SOC + Mist Therapy

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

MIST Therapy

Intervention Description

Non-contact low frequency ultrasound therapy

Primary Outcome Measure Information:

Title

Wound Area Mean Percent Reduction

Description

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.

Time Frame

4 weeks post baseline visit (randomization visit)

Secondary Outcome Measure Information:

Title

Heal Rates

Description

Compare rate of wound closure between study arms for 12 weeks post randomization. Descriptive statistics as not a powered endpoint.

Time Frame

12 weeks post randomization

Title

Change in Pain VAS Scores

Description

Time Frame

Baseline, 2 weeks and 4 weeks post randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Gibbons, MD

Organizational Affiliation

South Shore Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vicki Driver, DPM

Organizational Affiliation

Providence RI

Official's Role

Principal Investigator

Facility Information:

Facility Name

South Shore Hospital

City

Weymouth

State/Province

Massachusetts

ZIP/Postal Code

02189

Country

United States

12. IPD Sharing Statement

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Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers

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