- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01951859
Effects of a Homeopathic Anti-inflammatory Topical Cream on Ulcers and Neuropathy in the Diabetic Foot
A Double Blind Placebo Controlled Pilot Study to Evaluate the Effects of a Homeopathic Anti-inflammatory Topical Cream on the Healing of Wounds That Develop Into Ulcers and Neuropathy in the Diabetic Foot.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Oscar Alvarez, PhD
- Phone Number: 732-672-7291
- Email: oalvarez@calvaryhospital.org
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Recruiting
- Calvary Hospital Wound Care Clinic
-
Contact:
- Tashara Smith, BS
- Phone Number: 718-518-2577
- Email: tsmith@calvaryhospital.org
-
Contact:
- Oscar M Alvarez, PhD
- Phone Number: 718-518-2577
- Email: oalvarez@gmail.com
-
Principal Investigator:
- Dr. Oscar Alvarez, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Patient has clinical evidence of gangrene on any part of the affected foot.
- 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.
- Patient's ulcer has tunnels or sinus tracts that cannot be completely debrided.
- Patient's diabetes is uncontrolled and could interfere with the completion of the study.
- 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.
- Patient has or has had a malignant disease (other than cutaneous epithelioma) not in remission for five years or more.
- Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study.
- Patient has Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV).
- Patient has participated in another study utilizing an investigational drug or device within the previous 30 days.
- Patient's ulcer is infected or accompanied by active cellulitis, osteomyelitis as determined by the investigator
- Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Cream
|
|
Experimental: Topical Neuropathy/Ulcer Cream
an anti-inflammatory topical cream that contains homeopathic ingredients
|
This is a GRAS topical agent containing homeopathic ingredients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease in area or closure of wounds/fissures due to Homeopathic Anti-inflammatory Topical Cream
Time Frame: 12 weeks or wound closure
|
12 weeks or wound closure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oscar M Alvarez, PhD, Wound Care Cenetr Calvary Hospital, Bronx, NY
- Study Director: Martin Wendelken, RN, DPM, Podiatrist, Wound care center Calvary Hospital, Bronx, NY
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUC-DERM-0213-DFU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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