NanoDOX™ Hydrogel for chronic diabetic wounds

NewsBot · Sep 6, 2008

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Press Release:
Nanotherapeutics Files Investigational New Drug Application for NanoDOX™ Hydrogel to Treat Lower Extremity Diabetic Ulcers

ALACHUA, Fla.--(BUSINESS WIRE)--Nanotherapeutics, a privately held specialty biopharmaceutical company, announced today that it has submitted its first Investigational New Drug (IND) application to the FDA for a phase IIa
clinical study for its product NanoDOX™ Hydrogel, a topical doxycycline hydrogel for chronic wounds. The randomized double-blind study will assess the safety and efficacy of the product on the healing rates of non-infected diabetic ulcers
of the lower extremity. Assuming FDA approval, the Company expects to complete enrollment in early 2009.

The phase IIa study will be conducted at Veterans’ Administration hospitals in Florida. The Company will enroll diabetics, 18 and older, who have diabetic ulcers of the foot and lower limbs at the Gainesville and Lake City VA hospitals. The primary endpoint to evaluate the hydrogel’s efficacy will be the rate of complete (100%) wound closure during a 20-week treatment period.

“Diabetic ulcers are the primary cause of amputations of the leg, foot, or toe. Two-thirds of all lower extremity amputations in the United States are directly linked to diabetes. We believe that NanoDOX™ is a unique formulation that holds significant promise for the millions of people suffering from diabetic ulcers,” said Weaver H. Gaines, Chairman of the Board. “Filing the IND for the phase II study is a major step forward in our clinical program and demonstrates the strength of our technology and our capability to generate unique new product opportunities.”
NanoDOX™ Hydrogel, the company’s leading pharmaceutical product in development, is an alternative topical formulation of doxycycline.

Nanotherapeutics developed the product with its proprietary particle stabilization technology and formulated it to improve the topical delivery of doxycycline to increase local efficacy of the drug. Jim Talton, Ph.D., President of anotherapeutics, said, “The Company is also exploring the use of NanoDOX™ Hydrogel for treating traumatic open wounds incurred in combat. In collaboration with Walter Reed Army Medical Center, we plan a clinical trial to evaluate safety and efficacy in treatment of deep trauma wounds. A separate IND will be filed for this indication.”
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Admin2 · Sep 7, 2008

Related threads:
Other chronic wounds threads
Other wound products threads

Nanotherapeutics website

NewsBot · Oct 2, 2008

They have just registered this clinical trial:

Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers.

This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOXTM Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating Procedure(s) of the Department of Veterans Administration Hospitals. Patients with infected wounds will receive oral antibiotic and not included in the topical portion of the study until the infection is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all patients to receive SoC treatment for Diabetic Ulcers, patients would have either the investigational material or the placebo hydrogel applied as a part of their wound care. Each patient would receive 1.5gm packets of either the test article or the placebo hydrogel for a once-daily home treatment accompanied by a dressing change.
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NewsBot · Mar 7, 2022

Leveraging Potential of Nanotherapeutics in Management of Diabetic Foot Ulcer
Supriya Pandey et al
Exp Clin Endocrinol Diabetes. 2022 Mar 3

Diabetic foot ulcers (DFUs) are the most common complications associated with diabetes mellitus. DFUs are displayed as open sores or wounds located on the bottom of the foot as a secondary complication of diabetes mellitus (DM). DFUs are associated with significant morbidity and mortality and can subsequently lead to hospitalization and lower limb amputation if not recognized and treated on time. An immense challenge to conventional treatments is caused by the chronic nature of diabetic foot syndrome and it has led to the emergence of nanotechnology-based therapeutics. The greatest advantages of these nanotherapeutics are their unique biological, chemical, and physical properties. The present review highlights the augmentation of bacterial infections relating to delayed healing of DFUs and the potential of nanotherapeutics such as polymeric nanoparticles, metallic nanoparticles, siRNA-based nanoparticles, lipid nanoparticles, and nanofibers in accelerating wound healing in diabetic foot ulcers.
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NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

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