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Sponsored by: |
National Healing Corporation |
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Information provided by: | National Healing Corporation |
ClinicalTrials.gov Identifier: | NCT00273234 |
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 |
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Venous Ulcer |
Procedure: Autologous Platelet Gel (APG) |
Phase III |
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 |
Estimated Enrollment: | 70 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | November 2006 |
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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of venous insufficiency lower extremity (below knee) ulcer
Exclusion Criteria:
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 |
Principal Investigator: | Bob Bartlett, MD | National Healing Corporation |
Principal Investigator: | Steve Martin, PhD Candidate, Health Science | Touro University International |
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 |
Venous Ulcer autologous platelet healing |
Varicose Ulcer Skin Diseases Varicose Veins Ulcer |
Venous Insufficiency Vascular Diseases Skin Ulcer Leg Ulcer |
Pathologic Processes Cardiovascular Diseases |