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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01816633
Other study ID # CM002
Secondary ID
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


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
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