Credevo recently conducted clinical trial feasibility in Diabetic foot ulcer and the trial feasibility received overwhelming response from medical centers and sites. Total responses received were more than 1000% of number of sites actually sought for this trial.
The clinical study was a randomized, comparator-controlled, double-blind, multicenter phase-II trial and it aimed to evaluate the efficacy and safety of study medication in patients with Diabetic Foot Ulcer.
Sites targeted for this feasibility assessment were medical centers and sites located in United States.
Diabetic Foot Ulcer
A diabetic foot is a foot that exhibits any pathology that results directly from diabetes mellitus or any long-term complications of diabetes mellitus. Diabetic foot ulcer is a major complication of diabetes mellitus and probably the major component of the diabetic foot. It occurs in 15% of people with diabetes, and precedes 84% of all diabetes-related lower-leg amputations.
Summary of results
Feasibility data showed that not only there are many experienced and willing sites in United States for such clinical trial, but, more importantly, these sites actually had a lot of patients possible to be recruited in there.
The recruitment rate projection obtained from this trial was beyond expectations.
Due to overwhelming response, the feasibility was closed ahead of time.
Here are the salient results obtained from this feasibility
- Total responses received: >1000% of site requirement
- Average recruitment rate projection: 7 patients/site/month
- Highest recruitment rate reported: 50 patients / month
Shortlisted set of investigators were further assessed based on Credevo-specific learning from other feasibility studies and investigator-interactions.
Here is the set of investigators that Credevo recommends to contact for exploring your clinical study requirements.
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