Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers (DFU)
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| ClinicalTrials.gov Identifier: NCT01596920 |
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Recruitment Status :
Completed
First Posted : May 11, 2012
Last Update Posted : April 9, 2014
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The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator.
Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue Based Product (HCT/P) under Title 21 CFR Part 1271.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Foot Ulcers | Other: Tissue Other: Control | Phase 4 |
The treatment indication is for chronic, diabetic foot ulcers (DFUs) between 1cm2 and 15cm2 located below the malleoli on the plantar or dorsal surface of the foot. Patients must have confirmed Type I or Type II Diabetes.
Patients will receive treatment every week for 12 weeks duration in the Single-Blind Treatment phase of the trial.
Patients who receive Grafix® or control will be evaluated for primary efficacy up to 84 days, and for safety and wound re-occurrence for 84 days after wound closure. Patients in the control group whose wounds are not closed at the end of treatment may be offered Grafix® in an Open-Label Treatment phase. The Open-Label Treatment phase can last up to an additional 84 days.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 97 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Adaptive Design, Randomized, Single-Blind Study With an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Grafix® for the Treatment of Chronic Diabetic Foot Ulcers |
| Study Start Date : | April 2012 |
| Actual Primary Completion Date : | August 2013 |
| Actual Study Completion Date : | March 2014 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Grafix® |
Other: Tissue
Allograft Tissue Cellular Repair Matrix |
| Placebo Comparator: Control (non-adherent dressing) |
Other: Control
Non-adherent Dressing |
- Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator, anytime up to the Day 84 Visit [ Time Frame: Up to 84 days ]
- Time to initial wound closure [ Time Frame: Up to 84 days after the Single-Blind Treatment Visits ]
- number of patients with >50% reduction in wound size by Day 28 [ Time Frame: Up to 84 days after the Single-Blind Treatment Visits ]
- number of applications of Grafix® versus control [ Time Frame: Up to 84 days after the Single-Blind Treatment Visits ]
- number of re-occurrences of index wound post-healing [ Time Frame: Up to 84 days after the Single-Blind Treatment Visits ]
- percent of wounds achieving complete closure [ Time Frame: Up to 84 days after the Single-Blind Treatment Visits ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Between 18 years and 80 years of age inclusive, as of the date of screening
- Confirmed diagnosis of Type I or Type II Diabetes
- An Index Ulcer defined as chronic (presence of wound for > 4 weeks) but not present for more than 52 weeks at the Screening Visit
- Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot
- The Index Ulcer is between 1cm2 and 15 cm2 at the Screening Visit
- The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
- Wound is free of necrotic debris
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Patient has adequate circulation to the foot as documented by either:
- Ankle Brachial Index (ABI) > 0.70 and < 1.30, or
- In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30, a Toe Brachial Index (TBI) ≥ 0.50
- In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30 and TBI cannot be performed (e.g., toe is absent, wounds are present, or site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g., duplex imaging, normal pulse volume recording [PVR] testing).
Exclusion Criteria:
- Index Ulcer is of non-diabetic pathophysiology
- Gangrene is present on any part of the affected foot
- Index Ulcer is over an active Charcot deformity
- The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
- Patient is currently receiving dialysis
- Patient has a glycated hemoglobin A1c (HbA1c) level of > 12%
- Chronic oral steroid use > 7.5 mg daily
- Requiring intravenous (IV) antibiotics to treat the index wound infection
- Patient has an ulcer within 15cm of the Index Ulcer identified for study consideration
- Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
- Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
- Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site
- Patient has active malignancy other than non-melanoma skin cancer
- Patient's Index Ulcer has decreased by ≥ 30% during 1-week screening period as determined by criteria provided by the Wound Core Lab
- Patient's random blood sugar is > 450 mg/dl at screening
- Patient has untreated alcohol or substance abuse at the time of screening
- Pregnant women
- Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening
- Patient has allergy to primary or secondary dressing materials used in this trial
- Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596920
| United States, Alabama | |
| Institute for Advanced Wound Care at Baptist Medical | |
| Montgomery, Alabama, United States, 36111 | |
| United States, Arizona | |
| Clinical Trials of Arizona, Inc. | |
| Glendale, Arizona, United States, 85306 | |
| United States, California | |
| ILD Laser and Research Center | |
| Encinitas, California, United States, 92024 | |
| United States, Florida | |
| Nature Coast Clinical Research | |
| Inverness, Florida, United States, 34452 | |
| River City Clinical Research | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Georgia | |
| Aiyan Diabetes Center | |
| Evans, Georgia, United States, 30809 | |
| United States, New Jersey | |
| Ocean County Foot and Ankle Surgical Associates | |
| Toms River, New Jersey, United States, 08753 | |
| United States, North Carolina | |
| UNC at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| Ohio Health Research Institute | |
| Columbus, Ohio, United States, 43214 | |
| United States, Pennsylvania | |
| Blair Orthopedics Associates, Inc | |
| Altoona, Pennsylvania, United States, 16602 | |
| United States, Rhode Island | |
| Omega Medical Research | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, Texas | |
| UT Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| Clincal Trials of Texas, Inc. | |
| San Antonio, Texas, United States, 78229 | |
| Study Director: | Sharron E McCulloch | Osiris Therapeutics, Inc |
| Responsible Party: | Osiris Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01596920 History of Changes |
| Other Study ID Numbers: |
Osiris 302 |
| First Posted: | May 11, 2012 Key Record Dates |
| Last Update Posted: | April 9, 2014 |
| Last Verified: | April 2014 |
Keywords provided by Osiris Therapeutics:
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Chronic DFUs Diabetic Foot Ulcers |
Additional relevant MeSH terms:
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Ulcer Diabetic Foot Foot Ulcer Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer |
Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Foot Diseases |