Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner gd 1 and 2 Diabetic Foot Ulcers.

October 19, 2016 updated by: Cytomedix

A Multi-Center, Prospective, Clinical Trial Comparing the Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner 1 and 2 Diabetic Foot Ulcers

The purpose of this study is to determine if AutoloGel platelet rich plasma used on non healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and customary care

Study Overview

Status

Terminated

Conditions

Detailed Description

Autologel is a platelet-rich plasma gel used in the treatment of no-healing chronic wounds. Prospective observational studies of the effectiveness of Autologel have demonstrated promising results in regard to the healing of diabetic foot ulcers including severe Wagner grade 3 and 4 ulcers. The aim of the current trial is to compare the efficacy, measured as wound healing in a single-blind (assessor) randomized controlled trial, of usual and customary care with and without Autologel in treating Wagner 1 and 2 diabetic foot ulcers.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Forest General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Medicare 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 or 2 Diabetic Foot Ulcer (DFU; see Appendix 9 for Wagner Classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel). Subjects who have heel ulcers may be included if another, eligible wound is the index ulcer
  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 20 cm2
  7. Demonstrated adequate offloading regimen
  8. Duration ≥ 1 month at first visit (screening period)
  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. Wagner 3, 4, or 5 DFU (see Appendix 9 for Wagner Classification) Page 15 of 58
  3. Any clinically infected index ulcer that is apparent on Day 0. The presence of infection is defined by ≥ 2 classic findings of inflammation (erythema, warmth, tenderness, pain, or induration) or purulent secretions (Lipsky, 2012, or see Appendix 4)
  4. Presence of another wound that is concurrently treated and might interfere with index wound
  5. Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
  6. Presence of underlying osteomyelitis, or if osteomyelitis is suspected
  7. Received systemic corticosteroids or immunosuppressive agents, hyperbaric oxygen therapy (HBOT), electrostimulation, growth factors, or any cell or tissue-derived products for wounds during the 30 days preceding the screening visit; received radiation therapy or chemotherapy within previous 6 months
  8. Any malignancy other than non-melanoma skin cancer
  9. Ischemic ulcer defined as an ankle brachial index (ABI; handheld or Arterial Doppler) < 0.8 (note: if ABI is ≥ 1, then an skin perfusion pressure (SPP) or transcutaneous oximetry (TCOM) must be performed or the subject cannot be enrolled), TCOM < 30 mm Hg, or SPP < 30 mm Hg; toe pressure < 45 mm Hg. These measurements may be concurrent with the initial evaluation of the index ulcer or obtained within 90 days of study enrollment if done prior to that concurrence.
  10. Subject has radiographic evidence consistent with diagnosis of active Charcot foot
  11. Untreated Charcot foot or DFUs associated with a treated Charcot deformity in which reconstruction or offloading has not taken place
  12. Ulcer expected to be treated with any advanced therapeutics (e.g., HBOT)
  13. Ulcer area decreases by ≥ 30% during 2-week screening/run-in period
  14. Subjects who are cognitively impaired and do not have a healthcare proxy
  15. Serum albumin of less than 2.5 g/dL
  16. Plasma Platelet count of less than 100 x 109/L
  17. Hemoglobin of less than 10.5 g/dL
  18. Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration
  19. Subject requires or is anticipated to require interventions directed at improvement of arterial perfusion to affected area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AutoloGel
AutoloGel treatment
Treatment with Autologel and standard of care twice a week for the first two weeks and once a week thereafter
Other Names:
  • Autologel System
Other: Usual and Customary Care
Standard of care
Standard of care treatment twice weekly for 2 weeks then weekly
Other Names:
  • Standard of care clinically indicated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare time to heal in Wagner 1 and 2 diabetic foot ulcers at 12 weeks treated with AutoloGel versus usual and customary care
Time Frame: 12 weeks
Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at consecutive study visits 2 weeks apart. Initial diagnosis of healing by unblinding Principal Investigator will be confirmed by an independent blinded observer using digital photography, planimetry data and wound measurements
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess wound healing trajectory and change in Chronic Wound quality of Life W-QOL scores: and to assess the comparative safety of AutoloGel and usual and customary care
Time Frame: 13 weeks
QOL tool administered prior to and at the end of treatment to document the impact of the wound on the subject's life and whether treatment interventions helped a return to improved functioning.
13 weeks
Number of patients with adverse events as a measure of tolerability
Time Frame: 12 weeks
Frequency and severity of adverse events
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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