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

NCT01816672 | Terminated

• 1 other identifier: CM001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Foot Ulcer

Keywords

Wagner 1; Wagner 2; Non healing diabetic foot wound

Outcome Measures

Primary Outcomes (1)

• Compare time to heal in Wagner 1 and 2 diabetic foot ulcers at 12 weeks treated with AutoloGel versus usual and customary care

  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 Outcomes (2)

• 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

  13 weeks

• Number of patients with adverse events as a measure of tolerability

  12 weeks

Study Arms (2)

AutoloGel

ACTIVE COMPARATOR

AutoloGel treatment

Device: AutoloGel

Usual and Customary Care

OTHER

Standard of care

Other: Usual and Customary Care

Interventions

AutoloGel DEVICE

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

Also known as: Autologel System

AutoloGel

Usual and Customary Care OTHER

Standard of care treatment twice weekly for 2 weeks then weekly

Also known as: Standard of care clinically indicated

Usual and Customary Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medicare eligible
• ≥18 years of age
• Type I or II diabetes requiring medical treatment as determined by the physician
• 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
• 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)
• Debrided ulcer size between 0.5 cm2 and 20 cm2
• Demonstrated adequate offloading regimen
• Duration ≥ 1 month at first visit (screening period)
• Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

You may not qualify if:

• Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
• Wagner 3, 4, or 5 DFU (see Appendix 9 for Wagner Classification) Page 15 of 58
• 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)
• Presence of another wound that is concurrently treated and might interfere with index wound
• Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
• Presence of underlying osteomyelitis, or if osteomyelitis is suspected
• 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
• Any malignancy other than non-melanoma skin cancer
• 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.
• Subject has radiographic evidence consistent with diagnosis of active Charcot foot
• Untreated Charcot foot or DFUs associated with a treated Charcot deformity in which reconstruction or offloading has not taken place
• Ulcer expected to be treated with any advanced therapeutics (e.g., HBOT)
• Ulcer area decreases by ≥ 30% during 2-week screening/run-in period
• Subjects who are cognitively impaired and do not have a healthcare proxy
• Serum albumin of less than 2.5 g/dL

Sponsors & Collaborators

• Cytomedix: lead

Study Sites (1)

Forest General Hospital

Hattiesburg, Mississippi, 39401, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

US (1)