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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Calvary Hospital, Bronx, NY
Sponsor:
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier:
NCT01951859
First received: September 16, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 Intervention
Diabetic Neuropathy
Other: Neuropathy/Ulcer Homeopathic topical cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Calvary Hospital, Bronx, NY:

Primary Outcome Measures:
  • Decrease in area or closure of wounds/fissures due to Homeopathic Anti-inflammatory Topical Cream [ Time Frame: 12 weeks or wound closure ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951859

Contacts
Contact: Dr. Oscar Alvarez, PhD 732-672-7291 oalvarez@calvaryhospital.org

Locations
United States, New York
Calvary Hospital Wound Care Clinic Recruiting
Bronx, New York, United States, 10461
Contact: Tashara Smith, BS    718-518-2577    tsmith@calvaryhospital.org   
Contact: Oscar M Alvarez, PhD    718-518-2577    oalvarez@gmail.com   
Principal Investigator: Dr. Oscar Alvarez, PhD         
Sponsors and Collaborators
Calvary Hospital, Bronx, NY
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
  More Information

No publications provided

Responsible Party: Oscar M. Alvarez, PhD, Director, Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier: NCT01951859     History of Changes
Other Study ID Numbers: NUC-DERM-0213-DFU
Study First Received: September 16, 2013
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Foot
Diabetic Neuropathies
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014