A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers

Impaired Wound Healing Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02248077
• Other study ID #: CM-567
• Status: Withdrawn
• Phase: Phase 4
• First received: September 22, 2014
• Last updated: October 19, 2016
• Start date: October 2014

Study information

• Verified date: October 2016
• Source: Cytomedix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Centers for Medicare Services
• Study type: Interventional

Clinical Trial Summary

This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For DFU indication:

1. Medicare beneficiary

2. Males or females = 18 years of age

3. Type I or II diabetes requiring medical treatment as determined by the physician

4. The single wound to be applied Study Treatment (Index Ulcer) is a Wagner 1-4 DFU (see Section 17.12 Appendix 12 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot (including all toe surfaces and the heel)

5. Patients have been treated with UCC at the center for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available

6. For patients with multiple potential Index 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 patient should not be enrolled (screen failure)

7. Demonstrated offloading regimen

8. A wound age of = 30 days at the Screening Visit

9. Patient must be willing to comply with the protocol, which will be assessed by enrolling clinician.

10. Patient must sign an Informed Consent Form prior to any study-related procedures.

For VLU indication:

1. Medicare beneficiary

2. Males or females = 18 years of age

3. Diagnosed venous disease

4. Patients have been seen at the center/site for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available

5. The non-healing wound is located between the knee and ankle and may include ankle

6. For patients with multiple potential Index VLUs, 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 patient should not be enrolled (screen failure)

7. Demonstrated compression regimen

8. A wound age of = 30 days at the Screening visit

9. Patient must be willing to comply with the protocol, which will be assessed by enrolling clinician

10. Patient must sign an Informed Consent prior to any study-related procedures.

For PU indication:

1. Medicare beneficiary

2. Males or females = 18 years of age

3. Ulcer of pressure/shear etiology (Stage II, III, IV, see Section 17.13 Appendix 13 for stage definitions)

4. Patients have been seen at the site for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available

5. The single wound to be applied Study Treatment (Index Ulcer) that is located on the heel, ischium, sacrum, coccyx or trochanter

6. For patients with multiple potential PUs, 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 patient should not be enrolled (screen failure)

7. Demonstrated pressure relief regimen

8. A wound age of = 30 days at Screening visit

9. Patient must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

10. Patient must sign an Informed Consent prior to any study-related procedures.

Exclusion Criteria:

1. Patients 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 the treatment of the Index wound

3. Malignancy in wound bed

4. Active clinical wound infection.

5. Patient has inadequate venous access for repeated blood draw required for AutoloGel processing

6. Patients who are cognitively impaired and do not have a healthcare proxy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Impaired Wound Healing
• Leg Ulcer
• Pressure Ulcer
• Varicose Ulcer

Intervention

Device:
• AutoloGel

Other:
• Usual and Customary Care (UCC)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cytomedix

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Ulcer Closure	Proportion of patients with complete ulcer closure	12 weeks	No

External Links

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