AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Cytomedix
Sponsor:
Information provided by (Responsible Party):
Cytomedix
ClinicalTrials.gov Identifier:
NCT01819142
First received: March 21, 2013
Last updated: August 18, 2014
Last verified: July 2014
  Purpose

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort-controlled trial in which pressure ulcers will be treated using AutoloGel and standard care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care.


Condition Intervention Phase
Pressure Ulcer
Device: AutoloGel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/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 Stage II-IV Pressure Ulcers

Resource links provided by NLM:


Further study details as provided by Cytomedix:

Primary Outcome Measures:
  • Time to complete wound healing [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Compare complete wound healing at 16 weeks for all pressure ulcers treated with AutoloGel plus standard of care with case-matched concurrent controls. 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:
  • Ulcer recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Frequency of ulcer recurrence (recurrence defined as any new ulcer that has appeared since the Index Ulcer healed)

  • Proportion of healed ulcers [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Proportion of patients with completely healed pressure ulcers

  • W-QOL (Quality of Life with Chronic Wounds) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 weeks

  • Number of patients with adverse events as a measure of tolerability [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Frequency and severity of adverse events during the study


Estimated Enrollment: 400
Study Start Date: April 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AutoloGel
Subjects will be treated with AutoloGel 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 patients will receive Autologel treatment
Device: AutoloGel
AutoloGel is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly.
Other Name: Autologel System

Detailed Description:

Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of AutoloGel to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which pressure ulcers will be treated using AutoloGel and standard of care to determine time to heal at 16 weeks. Comparison will be made with a case matched 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. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
  4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter
  5. For subjects with potentially multiple eligible PUs, 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 3 cm2 and 200 cm2
  7. Demonstrated adequate offloading 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. Stage I pressure ulcers
  3. Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound
  4. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
  5. Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)
  6. Any malignancy other than non-melanoma skin cancer
  7. Subjects who are cognitively impaired and do not have a healthcare proxy
  8. Serum albumin of less than 2.5 g/dL
  9. Plasma Platelet count of less than 100 x 109/L
  10. Hemoglobin of less than 10.5 g/dL
  11. Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration.

10. Life expectancy of < 6 months.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819142

Contacts
Contact: Catherine Van Doren, RN cvandoren@cytomedix.com

Sponsors and Collaborators
Cytomedix
  More Information

No publications provided

Responsible Party: Cytomedix
ClinicalTrials.gov Identifier: NCT01819142     History of Changes
Other Study ID Numbers: CM004
Study First Received: March 21, 2013
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cytomedix:
non healing wound
pressure ulcer

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014