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Clinical trial report - conclusions

Summary

    The results of the ultrasound scan analysis show that the Synapse Accel-Heal® micro-current is having a significant effect on the wound and surrounding tissue.

Quality of life

One of the main challenges facing clinicians when treating chronic wounds is the management of oedema. The physical presence of copious amounts of fluid in tissue can inhibit wound repair and also damage surrounding intact tissue.

This over production of oedema can have a
significant effect, both on the patients quality of life and the cost of wound management due to the frequent dressing changes.

Synapse Accel-Heal® micro-current has been shown in the trial to dramatically reduce oedema, reduce patient pain and improve wound repair.

The clinical trial data set contained 28 patients all presenting with complicated non-healing wounds. In the largest sub-group of patients presenting with venous leg ulcers (VLU) the mean time of an open ulcer, before the start of the Accel-Heal treatment, was two years. The complete data set of patients comprised 22 venous leg ulcers, 1 arterial ulcer, 4 mixed leg ulcers and 1 pressure ulcer. The patients mean age was 69.2±11.4 years, 62% of which were female. In order to standardise the application of the Accel-Heal® treatment all patients were exposed to the same treatment duration. VLU size was interpolated and extrapolated to provide a continuous estimate of wound size over a period of 20 weeks from the start of the treatment with Accel-heal.

Conclusion

The results from the data set strongly indicate that whatever the presenting size of the wound the Accel-Heal® treatment should be applied continuously until the wound has reached 50% of its original size.

VLU with an area of 15cm2 would be expected to be healed to complete closure within eight weeks following this treatment prescription.

This suggests maximum efficacy of Accel-Heal® will be achieved when it is used in the early stages of a wounds presentation.

Graph 1 - Mean venous leg ulcer size treated with Accel-Heal®

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Graph 2 - Cumulative % change in ulcer size from baseline

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