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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951859
Recruitment Status : Unknown
Verified July 2014 by Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY.
Recruitment status was:  Recruiting
First Posted : September 27, 2013
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY

Tracking Information
First Submitted Date  ICMJE September 16, 2013
First Posted Date  ICMJE September 27, 2013
Last Update Posted Date July 23, 2014
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
Decrease in area or closure of wounds/fissures due to Homeopathic Anti-inflammatory Topical Cream [ Time Frame: 12 weeks or wound closure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Homeopathic Anti-inflammatory Topical Cream on Ulcers and Neuropathy in the Diabetic Foot
Official Title  ICMJE 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.
Brief Summary This is a study whose primary objective is to assess the effectiveness of Neuropathy/Ulcer Cream in the promotion of healing skin fissures plantar foot ulcers and as a moisturizer to prevent dry skin turning into ulcers as compared with a placebo cream containing the same vehicle as Neuropathy/Ulcer Cream without the active ingredients (Control).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy
Intervention  ICMJE Other: Neuropathy/Ulcer Homeopathic topical cream
This is a GRAS topical agent containing homeopathic ingredients
Other Name: Nan's Cream
Study Arms  ICMJE
  • Experimental: Topical Neuropathy/Ulcer Cream
    an anti-inflammatory topical cream that contains homeopathic ingredients
    Intervention: Other: Neuropathy/Ulcer Homeopathic topical cream
  • Placebo Comparator: Placebo Cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 24, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2015
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01951859
Other Study ID Numbers  ICMJE NUC-DERM-0213-DFU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
Study Sponsor  ICMJE Calvary Hospital, Bronx, NY
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Calvary Hospital, Bronx, NY
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP