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

NCT00273234 | Withdrawn Phase 3

• 1 other identifier: NHC-2006-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 6

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, Autologous Platelet Concentrate (APC), is a concentrate of cells in the bloodstream called platelets.

Conditions

Venous Ulcer

Keywords

Venous; Ulcer; autologous; platelet; healing

Outcome Measures

Primary Outcomes (1)

• Complete Healing

Secondary Outcomes (2)

• Percent Healing per unit of time (speed)

• Pain reduction

Interventions

Autologous Platelet Gel (APG) PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of venous insufficiency lower extremity (below knee) ulcer
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Healing Corporation: lead

Study Sites (6)

Palms of Pasadena Wound Healing Center

St. Petersburg, Florida, 33707, United States

Location

Parrish Wound Healing Clinic

Titusville, Florida, 32796, United States

Location

Anna Jacques Hospital Wound Healing Center

Newburyport, Massachusetts, 01950, United States

Location

Johnston Therapeutic Wound Clinic

Smithfield, North Carolina, 27577, United States

Location

Ohio State University East Wound Healing Center

Columbus, Ohio, 43205, United States

Location

East Texas Medical Center Wound Healing Center

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bob Bartlett, MD

  National Healing Corporation

  PRINCIPAL INVESTIGATOR

• Steve Martin, PhD Candidate, Health Science

  Touro University International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 4, 2006
• First Posted: January 9, 2006
• Study Start: January 1, 2006
• Study Completion: November 1, 2006
• Last Updated: March 6, 2007

Record last verified: 2007-03

Locations

US (6)