Status:
WITHDRAWN
Clinical Effectiveness of Topical Autologous Platelet Gel for the Treatment of Venous Ulcers
Lead Sponsor:
National Healing Corporation
Conditions:
Venous Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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, Autologo...
Detailed Description
The purpose of this Pilot clinical study is to make a preliminary clinical and procedural assessment of the treatment of chronic venous stasis ulcers with Autologous Platelet Gel. The information and ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00273234
Start Date
January 1 2006
End Date
November 1 2006
Last Update
March 6 2007
Active Locations (6)
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1
Palms of Pasadena Wound Healing Center
St. Petersburg, Florida, United States, 33707
2
Parrish Wound Healing Clinic
Titusville, Florida, United States, 32796
3
Anna Jacques Hospital Wound Healing Center
Newburyport, Massachusetts, United States, 01950
4
Johnston Therapeutic Wound Clinic
Smithfield, North Carolina, United States, 27577