Clinical Effectiveness of Topical Autologous Platelet Gel for the Treatment of Venous Ulcers - Full Text View

Sponsored by:	National Healing Corporation
Information provided by:	National Healing Corporation
ClinicalTrials.gov Identifier:	NCT00273234

Purpose

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.

Condition	Intervention	Phase
Venous Ulcer	Procedure: Autologous Platelet Gel (APG)	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Clinical Evaluation of the Safety and Effectiveness of Topical Autologous Platelet Gel (APG) for the Treatment of Lower Extremity Chronic Venous Insufficiency Ulcers. A Multicenter, Randomized, Controlled Clinical Trial

Further study details as provided by National Healing Corporation:

Primary Outcome Measures:

Complete Healing

Secondary Outcome Measures:

Percent Healing per unit of time (speed)
Pain reduction

Estimated Enrollment:	70
Study Start Date:	January 2006
Estimated Study Completion Date:	November 2006

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 knowledge gained in the Pilot Study will be used to refine the Investigational Plan under which a Pivotal Clinical Study will be conducted. One of the advantages of conducting a pilot study is that it might give advance warning about where the main research project could fail, where research protocols may not or cannot be followed, or whether proposed methods or instruments are inappropriate or too complicated to achieve the expected clinical outcomes. The Pilot Study will provide preliminary data with which to:

Assess the feasibility of a (full-scale) study/survey
Refine the clinical protocol procedures
Assess the likely success of proposed recruitment approaches
Identifying logistical problems which might occur using proposed methods
Estimating variability in outcomes to help determine sample size
Determine what resources (finance, staff) are needed for a planned study
Assess the proposed data collection and analysis techniques to uncover potential problems
Confirm the study objectives are feasible
Train researcher in the elements of the research process and protocol
Assess the magnitude of the difference in the effectiveness of the investigational treatment vs control treatment

The pilot study will provide supporting clinical data for an IDE application to FDA for approval to conduct a Pivotal Study of the safety and effectiveness of APG for the treatment of chronic venous stasis ulcers. The study will evaluate the hypothesis that treatment of a chronic venous ulcer with APG prepared from Autologous Platelet Concentrate (APC+) (and the associated autologous growth factors) and Topical Thrombin (TT) has the potential to accelerate the re-epithelialization process. Harvest Technologies will submit a marketing application to FDA to expand the labeling of the SmartPReP2® Platelet Concentrate System, including its accessory kits, with the specific indication to produce APC for the purpose of promoting healing of chronic venous ulcers of the lower extremity.

60 to 100 study subjects will be enrolled from six investigational sites in this single-phase clinical trial.

The SmartPReP®2 Platelet Concentrate System is a dedicated microprocessor-controlled centrifuge. The SmartPReP®2 centrifuge and its accessory, the APC+ Process Kit, are currently available and used to produce Autologous Platelet Concentrate. The Harvest SmartJet Dual Applicator Kit is legally marketed to apply autologous blood products (K000456, K011032, and K020252). Topical Thrombin (TT), (bovine origin), USP is an approved pharmaceutical (NDC 52604-7102-1) marketed by Jones Pharma, Inc. (Thrombin-JMI®) that is not supplied by Harvest and must be obtained by the practitioner.

This study will compare standard of care medical therapy with and without APC+ and TT. Therefore, the study ulcers of the Investigational Group will receive treatment with APC+ and TT as an adjunctive treatment modality in addition to standard therapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273234

Locations

United States, Florida
Palms of Pasadena Wound Healing Center
St. Petersburg, Florida, United States, 33707
Parrish Wound Healing Clinic
Titusville, Florida, United States, 32796
United States, Massachusetts
Anna Jacques Hospital Wound Healing Center
Newburyport, Massachusetts, United States, 01950
United States, North Carolina
Johnston Therapeutic Wound Clinic
Smithfield, North Carolina, United States, 27577
United States, Ohio
Ohio State University East Wound Healing Center
Columbus, Ohio, United States, 43205
United States, Texas
East Texas Medical Center Wound Healing Center
Tyler, Texas, United States, 75701

Sponsors and Collaborators

National Healing Corporation

Investigators

Principal Investigator:	Bob Bartlett, MD	National Healing Corporation
Principal Investigator:	Steve Martin, PhD Candidate, Health Science	Touro University International

More Information

Study ID Numbers:	NHC-2006-01
Study First Received:	January 4, 2006
Last Updated:	March 4, 2007
ClinicalTrials.gov Identifier:	NCT00273234
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Healing Corporation:

Venous
Ulcer
autologous
platelet
healing

Study placed in the following topic categories:

Varicose Ulcer
Skin Diseases
Varicose Veins
Ulcer

Venous Insufficiency
Vascular Diseases
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009