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

NCT01549860 | Completed Results DMC

• 1 other identifier: IN-BALANCE VLU
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Insufficiency; Venous Reflux; Lower Extremity Ulcer

Keywords

Venous Insufficiency; Reflux; Lower Extremity Ulcer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Heal Rates

  12 weeks post randomization

• Change in Pain VAS Scores

  Baseline, 2 weeks and 4 weeks post randomization

Study Arms (2)

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.

Device: MIST Therapy

Interventions

MIST Therapy DEVICE

Non-contact low frequency ultrasound therapy

SOC + Mist Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celleration, Inc.: lead

Study Sites (1)

South Shore Hospital

Weymouth, Massachusetts, 02189, United States

Location

MeSH Terms

Conditions

Venous Insufficiency; Leg Ulcer; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Pamela Unger
• Organization: VP Medical Affairs

punger@celleration.com

(952) 224-8755

Study Officials

• Gary Gibbons, MD

  South Shore Hospital

  PRINCIPAL INVESTIGATOR

• Vicki Driver, DPM

  Providence RI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: April 1, 2015
• Last Updated: July 30, 2015
• Results First Posted: July 30, 2015

Record last verified: 2015-07

Locations

US (1)