Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01816633
• Other study ID #: CM002
• Status: Terminated
• Phase: N/A
• First received: March 20, 2013
• Last updated: October 19, 2016
• Start date: October 2013
• Est. completion date: January 2015

Study information

• Verified date: October 2016
• Source: Cytomedix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
United States	HyperBarxs at Northside Forsyth	Cumming	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Cytomedix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to heal	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	12 weeks	No
Secondary	Ulcer recurrence	Frequency of ulcer recurrence defined as any new ulcer appearing after the index ulcer healed	1 year	Yes
Secondary	Incidence of amputations	Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.	1 year	Yes
Secondary	Proportion of completely healed ulcers	Proportion of patients with completely healed diabetic foot ulcers	12 weeks	Yes
Secondary	W-QOL (Quality of life with Chronic Wounds) score	Change in mean W-QOL (Quality of life with Chronic Wounds) score between baseline and 12 weeks	12 weeks	Yes
Secondary	Number of patients with adverse events as a measure of tolerability	Frequency and severity of adverse events	12 weeks	Yes