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

NCT ID: NCT01951859

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-02-28

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).

Conditions

Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Topical Neuropathy/Ulcer Cream

an anti-inflammatory topical cream that contains homeopathic ingredients

Group Type: EXPERIMENTAL

Neuropathy/Ulcer Homeopathic topical cream

Intervention Type: OTHER

This is a GRAS topical agent containing homeopathic ingredients

Placebo Cream

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Neuropathy/Ulcer Homeopathic topical cream

This is a GRAS topical agent containing homeopathic ingredients

Intervention Type: OTHER

Other Intervention Names

Nan's Cream

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Calvary Hospital, Bronx, NY

OTHER

Sponsor Role: lead

Responsible Party

Oscar M. Alvarez, PhD

Director, Center for Curative and Palliative Wound Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oscar M Alvarez, PhD

Role: PRINCIPAL_INVESTIGATOR

Wound Care Cenetr Calvary Hospital, Bronx, NY

Martin Wendelken, RN, DPM

Role: STUDY_DIRECTOR

Podiatrist, Wound care center Calvary Hospital, Bronx, NY

Locations

Calvary Hospital Wound Care Clinic

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dr. Oscar Alvarez, PhD

Role: CONTACT

oalvarez@calvaryhospital.org

732-672-7291

Facility Contacts

Tashara Smith, BS

Role: primary

tsmith@calvaryhospital.org

718-518-2577

Oscar M Alvarez, PhD

Role: backup

oalvarez@gmail.com

718-518-2577

Other Identifiers

NUC-DERM-0213-DFU

Identifier Type: -

Identifier Source: org_study_id