VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
11 februari 2020 uppdaterad av: Tactile Medical
Randomized Trial Comparing a Dual Action Pneumatic Compression System Against Multi-Layer Bandaging Systems: A Non-Inferiority Study
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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 continued multi-layer bandaging for up to 16 weeks.
Participants will be seen in clinic for treatment and evaluation of symptoms and quality of life.
Studietyp
Interventionell
Inskrivning (Faktisk)
56
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85012
- Phoenix VA Health Care System
-
Phoenix, Arizona, Förenta staterna, 85015
- Associated Foot and Ankle Specialists, LLC
-
Tucson, Arizona, Förenta staterna, 85710
- Arizona Regional Medical Research
-
-
California
-
Carlsbad, California, Förenta staterna, 92009
- ILD Research Center
-
Fresno, California, Förenta staterna, 93720
- Limb Preservation Platform - Northwest
-
Fresno, California, Förenta staterna, 93721
- Limb Preservation Platform - Downtown
-
Long Beach, California, Förenta staterna, 90822
- Long Beach VA Healthcare System
-
Los Angeles, California, Förenta staterna, 90024
- UCLA Medical Center
-
Los Angeles, California, Förenta staterna, 90073
- Greater Los Angeles VA Healthcare System
-
San Diego, California, Förenta staterna, 92161
- VA San Diego Healthcare System
-
Sylmar, California, Förenta staterna, 91342
- Olive View - UCLA Medical Center
-
-
Florida
-
Miami, Florida, Förenta staterna, 33136
- University of Miami
-
North Miami Beach, Florida, Förenta staterna, 33169
- Barry University Clinical Research
-
South Miami, Florida, Förenta staterna, 33143
- Foot and Ankle Institute of South Florida
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02118
- Boston Medical Center
-
-
New York
-
Stony Brook, New York, Förenta staterna, 11794
- Stony Brook University
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- UNC School of Medicine
-
-
Ohio
-
Toledo, Ohio, Förenta staterna, 43606
- Jobst Vascular Institute
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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: if subject had bilateral CVI, the limb that possessed the largest ulcer meeting study criteria was used as the study treatment limb for evaluation and documentation throughout the study. Non-study limbs received standard of care treatment as determined by the treating clinician.
- 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): VLU was defined by open skin lesion of the leg or foot that occurred in an area affected by venous hypertension.
- Ulcer duration: Non healing VLU ≥ 1 month but not greater than 24 months.
- Ulcer size ≥ 2cm² ≤ 50cm²: if there were multiple ulcers on the study limb, the largest ulcer was used as the study treatment ulcer for evaluation and documentation throughout the study. If two ulcers were separated by no more than one centimeter of normal skin, their areas were added together for study purposes.
- Three or fewer separate full thickness ulcers on the study limb: sum of the ulcer areas on the study limb must be ≤ 50 cm².
- Leg circumferences within the following range: Ankle - 12 to 44cm; Calf - 22 to 60cm; Below knee - 22 to 68cm.
- Able and willing to provide informed consent prior to study participation.
Exclusion Criteria:
- Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone.
- Target ulcer was 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 two weeks of enrollment: venous ultrasound must be completed after procedure to determine whether there is still venous insufficiency at the time of enrollment.
- History of skin sensitivity to any of the components of ACT, multi-layer bandages of 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 2 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 affected 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 2 weeks: low dose steroid administration (Prednisone up to 5 mg per day or equivalent) was allowable for an unlimited period of time. Topical steroid administration to peri-ulcer area or other skin was allowable but could not be applied to the ulcer itself.
- Currently pregnant or trying to become pregnant.
- Inability or unwillingness to participate in all aspects of study protocol.
- Exhibited any condition which, according to the Investigator, justified 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:
- Subject's target ulcer decreased in size by greater than 30% compared to the baseline area.
- Subject's target ulcer increased in size by greater than 50% compared to the baseline area.
- Subject's target ulcer measured less than 1.5cm² at the Randomization Visit.
- Subject appeared to have evidence of infection in any ulcer.
- The sum of the ulcer areas on the subject's study limb is > 50cm².
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Dual Action Pneumatic Compression Device
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
|
Dual action pneumatic compression device used to treat chronic VLUs.
Andra namn:
|
|
Aktiv komparator: Multi-layer bandaging
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
|
Multi-layer bandaging used to treated chronic VLUs
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of VLU Area Reduction
Tidsram: Changes from Baseline to 16 weeks
|
Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software.
|
Changes from Baseline to 16 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient-Reported Quality of Life
Tidsram: Changes from Baseline to 16 weeks
|
The Charing Cross Venous Ulcer Questionnaire assesses the patients' perception of their health when venous ulceration is present.
All items are scored so that a lower score defines a more favorable health state (a greater reduction is associated with improved quality of life).
In addition, each item is scored using a 1 to 5 range so that the lowest and highest possible scores are 0 and 100, respectively.
|
Changes from Baseline to 16 weeks
|
|
Outpatient Costs
Tidsram: Changes from Baseline to 16 weeks
|
Assessment of the effect of the Actitouch compared to a standard regimen of multi-layer bandaging on mean total outpatient costs per subject.
|
Changes from Baseline to 16 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: William Marston, MD, University of North Carolina, Chapel Hill
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2016
Primärt slutförande (Faktisk)
1 maj 2017
Avslutad studie (Faktisk)
1 juni 2017
Studieregistreringsdatum
Först inskickad
9 februari 2016
Först inskickad som uppfyllde QC-kriterierna
11 februari 2016
Första postat (Uppskatta)
12 februari 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 februari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 februari 2020
Senast verifierad
1 januari 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 6010
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .