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.

Exclusion Criteria:

1. Patient has clinical evidence of gangrene on any part of the affected foot.

2. The patient's ulcer is due to a nondiabetic etiology. Ulcers of arterial, venous
stasis, pressure, radiation, traumatic, rheumatoid, vasculitis, collagen vascular
disease,or other nondiabetic etiologies are not to be enrolled.

3. Patient's ulcer has tunnels or sinus tracts that cannot be completely debrided.

4. Patient's diabetes is uncontrolled and could interfere with the completion of the
study.

5. Patient has one or more medical condition(s), including renal, hepatic, hematologic,
neurologic, or immune disease that in the opinion of the Investigator would make the
patient an inappropriate candidate for this wound healing study.

6. Patient has or has had a malignant disease (other than cutaneous epithelioma) not in
remission for five years or more.

7. Patient is receiving oral or parenteral corticosteroids, immunosuppressive or
cytotoxic agents, or is anticipated to require such agents during the course of the
study.

8. Patient has Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus
(HIV).

9. Patient has participated in another study utilizing an investigational drug or device
within the previous 30 days.

10. Patient's ulcer is infected or accompanied by active cellulitis, osteomyelitis as
determined by the investigator

11. Patient has any condition(s) that seriously compromises the patient's ability to
complete this study.