A Cohort Trial Comparing AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers

This study is currently recruiting participants.
Verified December 2013 by Cytomedix
Sponsor:
Information provided by (Responsible Party):
Cytomedix
ClinicalTrials.gov Identifier:
NCT01817543
First received: March 21, 2013
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, cohort-controlled trial in which venous leg ulcers (VLU)n will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC)


Condition Intervention Phase
Venous Leg Ulcer
Device: AutoloGel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Cytomedix:

Primary Outcome Measures:
  • Time to wound closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Primary endpoint is time to wound healing after 12 weeks com pared with case matched controls receiving standard of care. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds ─ Developing Products for Treatment, 2006).


Secondary Outcome Measures:
  • Proportion of wounds healed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Comparison of proportion of wounds healed over 12 weeks

  • Frequency of ulcer recurrence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Frequency of ulcer recurrence over a 1 year period post treatment; recurrence is defined as any new ulcer appearing on the leg after the index ulcer has healed.

  • Change in Quality of Life with Chronic Wounds (W-QOL) Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks

  • Number of patients with adverse events as a measure of tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Frequency and severity of treatment emergent adverse events


Estimated Enrollment: 385
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AutoloGel
Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive Autologel treatment
Device: AutoloGel
Autologel is a platelet-rich plasma gel used in the treatment of non-healing wounds
Other Name: AutoloGel System

Detailed Description:

Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. AutoloGel is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, open-label trial in which venous leg ulcers will be treated using AutoloGel and standard of care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care

  Eligibility

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

Inclusion Criteria:

  1. Medicare/Medicaid eligible
  2. ≥18 years of age
  3. Proven venous disease
  4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located between and including the knee and the ankle
  5. For subjects with potentially multiple eligible VLUs, the largest ulcer will be selected. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
  6. Debrided ulcer size between 2 cm2 and 200 cm2
  7. Demonstrated adequate compression regimen
  8. Duration ≥ 1 month at first visit
  9. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

Exclusion Criteria:

  1. Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
  2. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
  3. Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
  4. Any malignancy other than non-melanoma skin cancer
  5. Subjects who are cognitively impaired and do not have a healthcare proxy
  6. Serum albumin of less than 2.5 g/dL
  7. Plasma Platelet count of less than 100 x 109/L
  8. Hemoglobin of less than 10.5 g/dL
  9. Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01817543

Contacts
Contact: Jackie Earabino, RN jearabino@cytomedix.com

Locations
United States, California
Recruiting
Arcadia, California, United States, 91007
Contact: Sato Rinoie, DPM    (626) 821 9323    rinoie@att.net   
Principal Investigator: Sato Rinoie, DPM         
United States, Georgia
HyperBarxs at Northside Forsyth Recruiting
Cumming, Georgia, United States
Contact: Belinda Marcus, MD    770-771-6400    bmarcus@hyperbarxs.com   
Principal Investigator: Belinda Marcus, MD         
Sponsors and Collaborators
Cytomedix
  More Information

No publications provided

Responsible Party: Cytomedix
ClinicalTrials.gov Identifier: NCT01817543     History of Changes
Other Study ID Numbers: CM003
Study First Received: March 21, 2013
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cytomedix:
venous leg ulcers
non healing wounds

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014