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AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers

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ClinicalTrials.gov Identifier: NCT01819142
Recruitment Status : Terminated (Protocol study design was re-worked in collaboration with CMS)
First Posted : March 27, 2013
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pressure Ulcer Device: AutoloGel

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2013
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Time to complete wound healing [ Time Frame: 16 weeks ]
    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 :
  1. Ulcer recurrence [ Time Frame: 1 year ]
    Frequency of ulcer recurrence (recurrence defined as any new ulcer that has appeared since the Index Ulcer healed)

  2. Proportion of healed ulcers [ Time Frame: 16 weeks ]
    Proportion of patients with completely healed pressure ulcers

  3. W-QOL (Quality of Life with Chronic Wounds) score [ Time Frame: 16 weeks ]
    Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 weeks

  4. Number of patients with adverse events as a measure of tolerability [ Time Frame: 16 weeks ]
    Frequency and severity of adverse events during the study


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819142


Locations
United States, Mississippi
Singing River
Pascagaula, Mississippi, United States
Sponsors and Collaborators
Cytomedix
More Information

Responsible Party: Cytomedix
ClinicalTrials.gov Identifier: NCT01819142     History of Changes
Other Study ID Numbers: CM004
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Cytomedix:
non healing wound
pressure ulcer

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