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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. 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
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY

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).

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Other: Neuropathy/Ulcer Homeopathic topical cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : August 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Topical Neuropathy/Ulcer Cream
an anti-inflammatory topical cream that contains homeopathic ingredients
Other: Neuropathy/Ulcer Homeopathic topical cream
This is a GRAS topical agent containing homeopathic ingredients
Other Name: Nan's Cream

Placebo Comparator: Placebo Cream

Primary Outcome Measures :
  1. Decrease in area or closure of wounds/fissures due to Homeopathic Anti-inflammatory Topical Cream [ Time Frame: 12 weeks or wound closure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01951859

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Contact: Dr. Oscar Alvarez, PhD 732-672-7291

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United States, New York
Calvary Hospital Wound Care Clinic Recruiting
Bronx, New York, United States, 10461
Contact: Tashara Smith, BS    718-518-2577   
Contact: Oscar M Alvarez, PhD    718-518-2577   
Principal Investigator: Dr. Oscar Alvarez, PhD         
Sponsors and Collaborators
Calvary Hospital, Bronx, NY
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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
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Responsible Party: Oscar M. Alvarez, PhD, Director, Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY Identifier: NCT01951859    
Other Study ID Numbers: NUC-DERM-0213-DFU
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Diabetic Neuropathies
Diabetic Foot
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases