Clinical Effectiveness of Topical Autologous Platelet Gel for the Treatment of Venous Ulcers

Withdrawn before enrolling · Phase 3

Conditions studied: Venous Ulcer

In brief

The purpose of this study is to compare the effectiveness of standard venous ulcer care to standard venous ulcer care plus a cell based product made from the patients own blood. This product, Autologous Platelet Concentrate (APC), is a concentrate of cells in the bloodstream called platelets.

Key facts

Study ID

NCT00273234

Run by

National Healing Corporation

People needed

70

Starts

2006-01-01

Expected to finish

2006-11-01

Last updated by the study team

2007-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of venous insufficiency lower extremity (below knee) ulcer
• 4 weeks
• Area of ulcer is 1 cm2 - 20 cm2
• Subject is receiving standard wound care
• ABI ≥ 0.8 or, if diabetic, TBI ≥ 0.8 on the study limb.
• Subject has adequate venous access for phlebotomy.
• Subject has access to reliable outpatient dressing care (self, family member, nursing staff, etc.)
• Hematocrit is > 30%
• Platelet Count is > 100,000
• INR < 1.3
• Subject has no known coagulopathies
• Serum Albumin > 2.5
• If diabetic, HgbA1C < 10%
• Venous reflux < 20 seconds by ultrasonography

You may not qualify if…

• Presence of arterial insufficiency (ABI or if diabetic TBI <0.8)
• Subject has received biological therapy within 30 days of enrollment
• Subject is receiving radiation therapy near the ulcer
• Active infection of the study wound, or osteomyelitis, or cellulitis has been diagnosed. The patient may be enrolled only after the infection has been controlled, including:
• Debridement if necessary
• Patient has received at least 2 weeks of appropriate antibiotics
• Allergy to bovine thrombin
• Alcohol or drug abuse within 6 months of enrollment
• Subject has been diagnosed with AIDS, HIV, or Hepatitis
• Subject is taking immunosuppressive therapy
• Subject is taking pentoxyfilline (Trental®)
• Steroid use within 7 days of enrollment
• Presence of a non-study ulcer within 2.0cm of the study ulcer
• Angioplasty by bypass or endovascular therapy within 4 weeks of enrollment
• Suspected sleep apnea
• Active Cancer
• BMI > 40 kg/m2
• Severe Rheumatoid Arthritis
• Collagen vascular disease
• Female who is pregnant or lactating or not using a reliable birth control method if of child-bearing age
• Wound bed with exposed bone, tendon, or fascia
• Renal insufficiency defined as Creatinine > 3 mg/dL
• Hepatic insufficiency defined as total Bilirubin > 2 mg/dL
• Enrollment, within the past 3 months, in any study related to wound healing
• Closure of study wound ≥ 40% within 2 screening visits of enrollment

Where it is running

• Palms of Pasadena Wound Healing Center — St. Petersburg, Florida, United States
• Parrish Wound Healing Clinic — Titusville, Florida, United States
• Anna Jacques Hospital Wound Healing Center — Newburyport, Massachusetts, United States
• Johnston Therapeutic Wound Clinic — Smithfield, North Carolina, United States
• Ohio State University East Wound Healing Center — Columbus, Ohio, United States
• East Texas Medical Center Wound Healing Center — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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