Clinical Trial: Effect of Deferoxamine on Wound Healing Rate in Patients With Diabetes Foot Ulcers

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effect of Deferoxamine on Wound Healing Rate in Patients With Diabetes Foot Ulcers

Brief Summary: Diabetic foot ulcer (DFU) is one of the most invalidating complication of diabetes and represents a big economic burden for the society. No specific therapy is available for diabetic foot ulcers.The aim of this study is to define a new approach for treatment of chronic diabetic wounds. Our concept is based on the improvement of the cellular reaction to hypoxia. It will address the transcriptional factor HIF-1 (Hypoxia inducible factor-1) which is the cellular sensor for oxygen and which is specifically repressed by hyperglycemia. The study will investigate the effect of local deferoxamine (0.66 mg/ml), the only known HIF-1 inducer, on the wound healing rate in patients with neuropathic diabetic foot ulcers. The primary objective of the study will be the reduction with >50% of the wound area after 12 weeks of treatment.

Detailed Summary:

Diabetes is reaching epidemic proportions and is predicted to affect 300 millions people worldwide in 2025. Chronic complications of diabetes represent the main concern for the modern therapy of diabetes and it has become a priority to further characterize their pathophysiological mechanisms to develop novel rational therapeutic strategies. It is a high need to identify additional mechanisms that contribute to the development of chronic complications of diabetes. Today's strategies aiming to improve blood glucose levels have limited efficiency mainly because they induce hypoglycemia when used in the optimal therapeutically range. It is therefore important to develop additional therapeutic strategies that can compensate the relative inefficient blood glucose control. There are other examples where "out of the box thinking" strategies such as treatment of hypertension have shown to be at least as efficient as glucose control to decrease morbidity and mortality in patients with diabetes.

Diabetic foot ulceration represents a major medical, social and economic problem. The lifetime risk of a person with diabetes for developing a foot ulcer is 25% and it is believed that every 30 seconds a lower limb is lost in the world due to diabetes. The condition is also followed by a high 5 years mortality which has been estimated to be 45% after ulceration and 79% after amputation. The mortality of the patients with DFU is worse than the mortality in patients with many common cancers.

The present clinical management for patients with DFU is limited and in consequence 40% of the ulcers are still not healed after one year of treatment. This limited efficacy of the present therapy is the consequence of the relative poor understanding of the pathophysiology of this complication. Even though prolonged exposure of the tissues to hype
Sponsor: Karolinska University Hospital

Current Primary Outcome: Healing [ Time Frame: 3 months ]

number of patients who have intact skin healing


Original Primary Outcome: Same as current

Current Secondary Outcome: Improvement of ulcer [ Time Frame: 3 months ]

the number of patients who have ulcer healing improvement of > 50%


Original Secondary Outcome: Same as current

Information By: Karolinska University Hospital

Dates:
Date Received: April 30, 2017
Date Started: June 1, 2017
Date Completion: December 31, 2022
Last Updated: April 30, 2017
Last Verified: April 2017