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Past Ulceration clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT01948479 Not yet recruiting - Diabetic Clinical Trials

Insole Optimisation for Ulcer Prevention: a Feasibility Trial

Start date: January 2014
Phase: N/A
Study type: Interventional

Insoles are designed to reduce increased loads and re-ulceration risk in patients with diabetes. The investigators previous research findings suggest that an instant insole solution may benefit some, but effectiveness is difficult to predict. The investigators propose a feasibility study using in-shoe pressure analysis to optimise the protective effect of insoles and footwear with the aim of reducing re-ulceration rates. Early indications from exploratory case studies within the real world clinical setting suggest that by implementing the investigators previous published research findings the investigators can optimise effectiveness and reduce outcome variability of protective footwear and insoles provided to patients at risk of re-ulceration. However a further randomised control trial is necessary to evaluate the effectiveness of in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear provision or 2) Routine insole and footwear provision, and temporary insole provision with optimisation. The findings from the feasibility study will inform protocol development for a larger clinical trial. The results of the feasibility study will be used to strengthen a protocol for a grant application to conduct the main RCT. A secondary output from the pilot study will be the dissemination of findings in a peer reviewed journal and at conference.