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

NCT ID: NCT01816672

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-07-31

Brief Summary

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

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AutoloGel

AutoloGel treatment

Group Type: ACTIVE_COMPARATOR

AutoloGel

Intervention Type: DEVICE

Treatment with Autologel and standard of care twice a week for the first two weeks and once a week thereafter

Usual and Customary Care

Standard of care

Group Type: OTHER

Usual and Customary Care

Intervention Type: OTHER

Standard of care treatment twice weekly for 2 weeks then weekly

Interventions

AutoloGel

Treatment with Autologel and standard of care twice a week for the first two weeks and once a week thereafter

Intervention Type: DEVICE

Usual and Customary Care

Standard of care treatment twice weekly for 2 weeks then weekly

Intervention Type: OTHER

Other Intervention Names

Autologel System; Standard of care clinically indicated

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytomedix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Forest General Hospital

Hattiesburg, Mississippi, United States

Countries

United States

Other Identifiers

CM001

Identifier Type: -

Identifier Source: org_study_id