Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic

Status Terminated

Clinical Trial Summary

This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the wound or surrounding tissue; or both; compared to patients treated with usual medical treatment . This study seeks to enroll patients who are 18 or older with a non-healing skin wound that is at least 30 days old. Only patients with Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers will be included in the study.

Clinical Trial Description

The proposed investigation is designed to solicit a large number of patients (N=1,500) with non-healing wounds (Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers) that have not responded to standard wound care in the previous 30 days or more. A prospective, interventional, single-blinded, controlled, registry trial will be used. Data will be analyzed to compare patients who received PRP therapy (PRP gel application, PRP injection, or both) and standard wound care (usual customary care) with patients who received standard wound care (usual customary care), only. Wound size, rate of healing, quality of life, and recurrence of wound will be measured during the 16-week period at usual office visits.

Hypotheses to be tested:

1. Treatment of a chronic wound with standard of care and autologous platelet rich plasma (PRP) will increase the velocity of healing (rate of wound closure) over a twenty week period as compared to patients receiving standard wound care only (Control Group), which results in the patient's ability to return to previous function and resumption of normal activities.

2. Treatment of a chronic wound with standard of care and autologous platelet rich plasma (PRP) will result in complete wound healing within twenty weeks, whereas complete wound healing will not be observed within twenty weeks in patients receiving standard wound care only (Control Group). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02071979
Study type	Interventional
Source	Arteriocyte, Inc.
Contact
Status	Terminated
Phase	N/A
Start date	April 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02652754` - Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers	Phase 1
Completed	`NCT01070433` - A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers	Phase 2
Completed	`NCT00971048` - Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds	N/A
Terminated	`NCT00762138` - The AutoloGel™ Post-Market Surveillance (TAPS) Program	N/A
Completed	`NCT00578604` - Non-Invasive Assessment of Wound Healing With Optical Methods	N/A
Completed	`NCT05417425` - Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers	Phase 1
Completed	`NCT02631512` - Evaluation of Woulgan in Diabetic Foot Ulcer	Phase 4
Terminated	`NCT01816633` - Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers	N/A
Completed	`NCT02222376` - Effect of Topic Pirfenidone in Diabetic Ulcers	Phase 3
Completed	`NCT01221207` - Instant Total Contact Cast to Heal Diabetic Foot Ulcers	N/A
Completed	`NCT01454401` - LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers	N/A
Withdrawn	`NCT01105884` - Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers	N/A
Completed	`NCT01291160` - Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers	Phase 2/Phase 3
Completed	`NCT00536744` - Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers	Phase 3
Terminated	`NCT00316537` - Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers	Phase 1/Phase 2
Completed	`NCT00013299` - Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3	Phase 2
Completed	`NCT00013286` - A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk	Phase 2
Terminated	`NCT02667327` - A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer	Phase 3
Not yet recruiting	`NCT00916292` - Safety Study of Topical Human FGF-1 for Wound Healing	Phase 1
Completed	`NCT01154374` - A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds — CMS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms