Diabetic NeuropathyNCT01951859
Effects of a Homeopathic Anti-inflammatory Topical Cream on Ulcers and Neuropathy in the Diabetic Foot
A study testing Neuropathy/Ulcer Homeopathic topical cream in people with Diabetic Neuropathy, run by Calvary Hospital, Bronx, NY at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Neuropathy/Ulcer Homeopathic topical cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Calvary Hospital Wound Care Clinic
The Bronx, New York, 10461
Tashara Smith, BS, 718-518-2577, tsmith@calvaryhospital.org
Oscar M Alvarez, PhD, 718-518-2577, oalvarez@gmail.com
About this study
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.
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
- Being tested
- Neuropathy/Ulcer Homeopathic topical cream
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropathy/Ulcer Homeopathic topical creamOther
Also called Nan's Cream
This is a GRAS topical agent containing homeopathic ingredients
| Study group | Role | What they receive |
|---|---|---|
| Topical Neuropathy/Ulcer Cream | Experimental | an anti-inflammatory topical cream that contains homeopathic ingredients Receives: Other: Neuropathy/Ulcer Homeopathic topical cream |
| Placebo Cream | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in area or closure of wounds/fissures due to Homeopathic Anti-inflammatory Topical Cream
Measured: 12 weeks or wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calvary Hospital, Bronx, NY
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
- Investigators
- Oscar M Alvarez, PhD, Principal investigator, Wound Care Cenetr Calvary Hospital, Bronx, NYMartin Wendelken, RN, DPM, Study director, Podiatrist, Wound care center Calvary Hospital, Bronx, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951859
- Sponsor's protocol ID
- NUC-DERM-0213-DFU
- Status last verified
- Jul 2014
- First submitted
- 16 Sep 2013
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01951859
- Acronym / sponsor ID
- NUC-DERM-0213-DFU
- Conditions
- Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Calvary Hospital, Bronx, NYUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Neuropathy/Ulcer Cream | Experimental | Other: Neuropathy/Ulcer Homeopathic topical creaman anti-inflammatory topical cream that contains homeopathic ingredients |
| Placebo Cream | Placebo comparator | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropathy/Ulcer Homeopathic topical creamAlso: Nan's CreamThis is a GRAS topical agent containing homeopathic ingredients | Other | Topical Neuropathy/Ulcer Cream |
Primary outcome
Decrease in area or closure of wounds/fissures due to Homeopathic Anti-inflammatory Topical Cream
Time frame: 12 weeks or wound closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar M Alvarez, PhD principal investigator
Wound Care Cenetr Calvary Hospital, Bronx, NY
Martin Wendelken, RN, DPM study director
Podiatrist, Wound care center Calvary Hospital, Bronx, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropathy/Ulcer Homeopathic topical cream in people with Diabetic Neuropathy, run by Calvary Hospital, Bronx, NY at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Oscar Alvarez, PhD (732-672-7291, oalvarez@calvaryhospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in area or closure of wounds/fissures due to Homeopathic Anti-inflammatory Topical Cream (time frame: 12 weeks or wound closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.