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

This study is currently recruiting participants. (see Contacts and Locations)
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

March 21, 2013
December 2, 2013
October 2013
June 2015   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01817543 on ClinicalTrials.gov Archive Site
  • 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
  • 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 W-QOP 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 adverse events, change in vital signs and physical examination from baseline
Not Provided
Not Provided
 
A Cohort Trial Comparing AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers
A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers

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)

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

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Leg Ulcer
Device: AutoloGel
Autologel is a platelet-rich plasma gel used in the treatment of non-healing wounds
Other Name: AutoloGel System
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
Intervention: Device: AutoloGel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
385
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jackie Earabino, RN jearabino@cytomedix.com
United States
 
NCT01817543
CM003
Yes
Cytomedix
Cytomedix
Not Provided
Not Provided
Cytomedix
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP