Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area closure at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.

Official Title

Randomized Trial Comparing a Dual Action Pneumatic Compression System Against Multi-Layer Bandaging Systems: A Non-inferiority Study

Details

Participants with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before being randomly assigned to either treatment using a dual action pneumatic compression device or multi-layer bandaging for up to 16 weeks. Participants will be seen in clinic for treatment, evaluation, complete symptom and quality of life questionnaires.

Keywords

Venous Leg Ulcer venous stasis ulcer wound chronic venous insufficiency Leg Ulcer Varicose Ulcer Dual Action Pneumatic Compression Device Multi-Layer Bandaging

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subject must be ≥ 18 years of age or legal age at the time of enrollment.
  • Chronic venous insufficiency confirmed by ultrasound within previous 12 months or prior to randomization.
  • Must have at least one of the following within the past six (6) months: Dorsalis Pedis(DP) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic patients on study limb; Posterior Tibial (PT) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic patients on study limb; Transcutaneous partial pressure oxygen (TcP02) > 30mmHg; Great toe systolic pressure > 40mmHg
  • Active ulceration (CEAP classification of C6)
  • Ulcer duration: Non healing VLU ≥ 1 month but not greater than 24 months.
  • Ulcer size ≥ 2cm2 ≤ 50cm2
  • Three or fewer separate full thickness ulcers on the study limb.
  • Leg circumferences within the following range:Ankle - 12 to 44cm; Calf - 22 to 60cm;Below knee - 22 to 68cm
  • Must be able and willing to provide informed consent prior to study participation.

You CAN'T join if...

  • Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle,or bone.
  • Target ulcer is of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy).
  • Treatment of the target ulcer with living cellular therapy within 30 days of the time of projected randomization.
  • Endovenous ablation or other venous surgery within one week of enrollment
  • History of skin sensitivity to any of the components of AT, multi-layer bandages or compression garments.
  • History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last three (3) months.
  • Acute thrombophlebitis within the last six (6) weeks.
  • History of pulmonary edema or decompensated congestive heart failure within six (6)weeks of screening.
  • Currently has an active infection of the skin on the target limb such as cellulitis requiring antibiotics.
  • History of target limb cancer within the last two years with the exception of treated non-melanoma skin cancer unless ulcer biopsy performed at screening is negative for neoplasia.
  • Active cancer receiving chemotherapy and/or radiation therapy.
  • Poorly controlled diabetes with an HbA1c value of > 12% within the past three (3)months.
  • Changes to medications that affect edema within the last 30 days prior to enrollment(e.g. diuretics, calcium channel blockers of the dihyropyridine class, pioglitazone,cox-1 inhibitors, pregabalin, and gabapentin, diltiazem or fluctuating doses of systemic steroids).
  • Use of systemic corticosteroids requiring daily administration at doses greater than 5mg of Prednisone per day or equivalent for greater than two weeks.
  • Currently pregnant or trying to become pregnant.
  • Inability or unwillingness to participate in all aspects of study protocol.
  • Exhibit any condition which, according to the Investigator, justifies the subject's exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable.
  • Currently participating in another clinical trial.

Additional Exclusion Criteria after two week run-in:

  • If ulcer area has decreased by greater than 30% compared to baseline area.
  • Ulcers measuring less than 1.5cm² after the run in will be excluded.
  • Any ulcer appearing to have evidence of infection.
  • Ulcers increasing in size greater than 50% after run in also excluded.
  • If the sum of the ulcer areas on the study limb is > 50cm2 the subject is excluded.

Locations

  • VA San Diego Healthcare System
    San Diego California 92161 United States
  • ILD Research Center
    Carlsbad California 92009 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tactile Medical
ID
NCT02680834
Study Type
Interventional
Last Updated