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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

NCT00215735

Diabetes

TERMINATED NA

A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers

NCT00338702

Diabetic Foot Ulcer

WITHDRAWN PHASE4

Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers

NCT02148302

Impaired Wound Healing Venous Insufficiency of Leg Diabetic Ulcers

TERMINATED NA

Autologous Platelet-Rich Plasma Therapy in the Treatment of Pyoderma Gangrenosum

NCT05984654

Pyoderma Gangrenosum

WITHDRAWN NA

Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds

NCT02307448

Foot Ulcer Chronic Skin Ulcer Venous Stasis Chronic Pressure Ulcer

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autologous Platelet Gel (APG)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No