Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01816633
Recruitment Status : Terminated (Protocol study design was re-done in collaboration with CMS)
First Posted : March 22, 2013
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Cytomedix

Brief Summary:
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 diabetic foot ulcers (DFU) will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC) as provided in up to 30 U.S. Wound Registry Research Network (USWRRN) centers.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Device: AutoloGel Not Applicable

Detailed Description:
AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. Prospective observational studies of the effectiveness of AutoloGel have demonstrated promising results in regard to the healing of DFUs, including severe Wagner grade 3 and 4 ulcers. 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 diabetic foot ulcers will be treated using AutoloGel to determine the time to heal at 12 weeks. Comparison will be made with a case-matched concurrent cohort of patients receiving undefined Usual and Customary Care (UCC).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 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 All Wagner Grades of Diabetic Foot Ulcers
Study Start Date : October 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly




Primary Outcome Measures :
  1. Time to heal [ Time Frame: 12 weeks ]
    The primary objective of the trial is to determine the time to heal diabetic foot ulcers treated with Autologel and Standard of Care at 12 weeks DFUs. Comparison will be made with a concurrent cohort of case matched subjects


Secondary Outcome Measures :
  1. Ulcer recurrence [ Time Frame: 1 year ]
    Frequency of ulcer recurrence defined as any new ulcer appearing after the index ulcer healed

  2. Incidence of amputations [ Time Frame: 1 year ]
    Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.

  3. Proportion of completely healed ulcers [ Time Frame: 12 weeks ]
    Proportion of patients with completely healed diabetic foot ulcers

  4. W-QOL (Quality of life with Chronic Wounds) score [ Time Frame: 12 weeks ]
    Change in mean W-QOL (Quality of life with Chronic Wounds) score between baseline and 12 weeks

  5. Number of patients with adverse events as a measure of tolerability [ Time Frame: 12 weeks ]
    Frequency and severity of adverse events



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Medicare/Medicaid eligible
  2. ≥18 years of age
  3. Type I or II diabetes requiring medical treatment as determined by the physician
  4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
  5. For subjects with potentially multiple eligible DFUs, 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 0.5 cm2 and 50 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. Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by AutoloGel (malignancy in nearby wound)
  3. Ulcer not of DFU pathophysiology (e.g., venous, 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.

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): NCT01816633


Locations
Layout table for location information
United States, California
Arcadia, California, United States, 91007
United States, Georgia
HyperBarxs at Northside Forsyth
Cumming, Georgia, United States
Sponsors and Collaborators
Cytomedix

Layout table for additonal information
Responsible Party: Cytomedix
ClinicalTrials.gov Identifier: NCT01816633     History of Changes
Other Study ID Numbers: CM002
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Cytomedix:
non healing wound

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases