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How do we Prove that our device increases arterial circulation in Diabetic feet?

Discussion in 'Diabetic Foot & Wound Management' started by Selwyn Firth, Jan 5, 2013.

  1. Selwyn Firth

    Selwyn Firth Member


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    My name is Selwyn Firth. I am not a Podiatrist but rather ahave a Masters degree in Chemical Engineering. I have also had Type 1 diabetes for 52 years. I am working for a company which has a mechanical calf compression device which has been proven to increase venous return to the heart. However many doctors say that even though the circulatory system is a closed loop( actually it is composed of numerous closed loops between the arterial supply and the venous return ) that does not prove that there is an increase in arterial flow. They require more proof, but will not define what that proof should be.

    I have been tested using laser Doppler and ABI showing I have calcification in my lower arteries. In consideration of this I found a local clinic where I was able to have my circulation tested using transcutaneous oxygen measurements with and without the device.

    W o L Calf pO2 = 54 mm Hg Left foot 44 mm Hg

    WO R calf pO2 = 67 mm Hg R foot 23 mm Hg

    The following day testing with the device applied to my right calf and operating at high speed 10 cycles per minute. the values were

    L C 69 L F 65 R C 85 RF 36.

    As can be seen from the numbers there was a significant increase in the subject leg

    The increase ranged from 56 % to a modest 27 %.

    This has not impressed the several wound care specialists we have contacted. This is why I am posting this request. We need feedback so that a suitable testing protocol can be deviced to further prove the effectiveness of our device. It has already shown promise in treating 12 patients who had poor circulation and non healing wounds. All 12 healed in less than 30 days, but again this was just an evaluation to see if the device could make a difference.

    If you are interested in finding out more feel free to email me your request. If you are willing to record the results of the device for your patients w diabetic ulcers arrangements can be made for products at no charge provided you are willing to sign usage agreements.

    I will be having a consecutive test performed Mon Jan 8 using 2 devices. I will post the results here.
    If you have any questions please email me selwyn@selwynfirth.com
     
  2. Craig Payne

    Craig Payne Moderator

    Articles:
    8
    You need a prospective randomised controlled trial with one group getting the intervention adn one group not getting. The assessments of the circulation (eg ankle brachial index, but preferably more validated measures) needs to be done by someone at baseline and follow-up who does not know if they got the intervention or not.
     
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