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

Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549860
• Other study ID #: IN-BALANCE VLU
• Status: Completed
• Phase: N/A
• First received: March 7, 2012
• Last updated: July 2, 2015
• Start date: April 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Celleration, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 venous ulcers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: April 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Lower Extremity Ulcer
• Ulcer
• Varicose Ulcer
• Venous Insufficiency
• Venous Reflux

Intervention

Device:
• MIST Therapy
Non-contact low frequency ultrasound therapy

Locations

Country	Name	City	State
United States	South Shore Hospital	Weymouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Celleration, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks post baseline visit (randomization visit)	No
Secondary	Heal Rates	Compare rate of wound closure between study arms for 12 weeks post randomization. Descriptive statistics as not a powered endpoint.	12 weeks post randomization	No
Secondary	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.	Baseline, 2 weeks and 4 weeks post randomization	No