End Points For Clinical Trials In Diabetic Neuropathy

Among the challenges for studies of diabetic neuropathy is the selection of the measures that can be used to determine the efficacy of the agents. Common end points include:

1. Subjective measures of symptoms (e.g., nerve symptom scores).

2. Questionnaires that allow for quantification of any changes in the symptoms of diabetic neuropathy, or the quality of life of the patient (e.g., neuropathy symptom scores, total neuropathy scores).

3. Objective neurological examinations focussing on distal sensorimotor function, including combinations giving a single score (e.g., NTSS-6, a combination of numbness, prickling sensation, aching pain, burning pain, lancinating pain, and allodynia scores).

4. Electrophysiology (nerve conduction velocity, amplitudes [especially sural nerve amplitude], F-wave latencies).

5. Quantitative tests of sensory and motor modalities that allow more precise measures of nerve function.

6. Autonomic measures (e.g., cardiac function or neurovascular measures).

7. Skin biopsy, which allows direct observation of the morphology of sensory nerve fibers.

8. Instruments that entail various combinations of the above.

The following summarizes the view of prospective end points in diabetic neuropathy trials:

Table 1

Mechanisms for Pathogenesis of Diabetic Neuropathy and Therapies That Have Been Tested Addressing Them

Table 1

Mechanisms for Pathogenesis of Diabetic Neuropathy and Therapies That Have Been Tested Addressing Them

Peripheral Neuropathy Natural Treatment Options

Peripheral Neuropathy Natural Treatment Options

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