Our next step in the development process is to discuss these results with the FDA in an end-of-phase II meeting, and to advance development into phase III. These results are transformational for Derma Sciences and we are looking forward to sharing these data with potential development and commercial partners, and to determining how best to maximize the considerable potential of DSC for our shareholders. We are hopeful that a phase III study will show comparably robust results and that, in due course, DSC will be brought to market to alleviate the suffering of millions of patients with these debilitating and stubborn wounds.
In the US, diabetes has reached epidemic proportions. According to the American Diabetes Association, about 24 million people 8 per cent of the US population have diabetes, and nearly 2 million new cases are diagnosed in people age 20 years or older each year. Up to 25 per cent of people with diabetes will develop a diabetic foot ulcer, resulting in 3 million diabetic foot ulcers annually in the US alone. According to the World Health Organization, at least million people worldwide have diabetes, a number that is expected to more than double by , due mainly to obesity and aging.
DSC, a novel angiotensin analogue, has been shown to improve epithelialization, granulation and vascularization, accelerating wound healing in a variety of normal and diabetic animal models. If there are two ulcers of the same size and the same Wagner Grade, the one present for the longest qualifying time will be the Target ulcer.
A female subject of childbearing potential who practices abstinence is not required to employ birth control. Has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures Exclusion Criteria: Has a known hypersensitivity to any of the investigational drug or vehicle components Has been exposed to any investigational agent within 30 days of entry into the study A female who is pregnant or nursing Has active malignant disease of any kind except for basal cell carcinoma of the skin.
A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. Has a hemoglobin of less than 8. Any antibiotic therapy must be completed or discontinued at screening. Any other finding, which in the opinion of the Investigator, may interfere with the assessment of the product or participation of the subject in the study.
Contacts and Locations. Information from the National Library of Medicine 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. More Information. National Library of Medicine U. National Institutes of Health U.
Department of Health and Human Services. 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. At Screening and Baseline prior to randomization , subject has at least one ulcer that fulfills all of the following criteria:. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : December 12, Study Description.
FDA Resources. Arms and Interventions. Gel will be applied to the wound once daily for four weeks treatment period. Outcome Measures. Average time to complete re-epithelialization of baseline ulcer area. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Have at least one chronic non-healing Wagner Grade 1 or Grade 2 plantar neuropathic diabetic ulcer between 1.
ABI greater than 0. Contacts and Locations. Information from the National Library of Medicine 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. More Information.
NorLeu3-A stimulation of diabetic foot ulcer healing: results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial. Wound Repair Regen. Epub Jun 7. Effect of NorLeu3-A on scar formation over time after full-thickness incision injury in the rat. Acceleration of healing, reduction of fibrotic scar, and normalization of tissue architecture by an angiotensin analogue, NorLeu3-A
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