Effects of a Homeopathic Anti-inflammatory Topical Cream on Ulcers and Neuropathy in the Diabetic Foot

Inclusion Criteria

• •1\. Patient is 18 years old or older.
• •2\. Patient has a current diagnosis of diabetes (Type 1 or 2).
• •3\. Patient's fissure or foot ulcer is on the plantar surface of the foot.
• •4\. Patient's fissure or ulcer is at least a partial thickness wound extending through the epidermis and at least part of the dermis. The wound may extend through the dermis and into subcutaneous tissue (granulation tissue may be present), but without exposure of muscle, tendon, bone, or joint capsule (Wagner Grade 1).
• •5\. Patient's wound is free of necrotic debris and clinical infection, should be comprised of healthy, vascular tissue.
• •6\. Patient's Ankle-Brachial Index (ABI) by Doppler is 0.7.
• •7\. The patient has adequate circulation to the foot to allow for healing.
• •This must be demonstrated by either of the following methods:
• •The patient has a palpable pulse on the study foot (either dorsalis pedis, posterior tibial, or peroneal artery) and has clinical signs of adequate circulation in the foot (e.g., toes are warm and pink).
• •If either there are no palpable pulses or clinical signs of adequate circulation are lacking, the Investigator must perform an additional assessment to assure that there is adequate circulation to the foot. Transcutaneous oxygen tension (TcPo2), photoplethysmography (PPG), Toe-Arm Index, Doppler wave form, Cardiosynchronous Limb Compression (CSC), Pulse Volume Recording (PVR) or exercise Ankle-Brachial Index (ABI). Determination of adequate circulation must be according to generally accepted criteria for the particular test employed. The additional assessments must be documented in the patient's source document and Case Report Form.
• •8\. Patient's diabetes is under control as determined by the Investigator from daily glucometer diary entries.
• •9\. Patient and caregiver are willing to participate in the clinical study and can comply with the follow-up regimen.
• •10.Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment.