Nu-3 Gel for Infected Diabetic Foot Ulcers
ConditionDiabetic Foot Infection
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLakewood-Amedex Inc
About this trial
The goal of this clinical trial is to test a topical drug in patients with mild infections of their diabetic foot ulcer. The main questions it aims to answer are:
What strength does the drug need to be in order to make the infection better? How frequently does the drug need to be applied in order to make the infection better? Participants will be asked to apply the medicine on their foot ulcer twice a day for 2 weeks and remain off of that foot during that time.
Participants will receive the medication either once a day or twice a day, in either a 5% or 10% gel, or placebo.
Researchers will compare the 5% and 10% gels to placebo to see if the infection improves.
Eligibility criteria
Qualifiers
1. Male and female subjects ≥18 years of age. 2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable.
Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg
Ankle Branchial Index (ABI) between 0.9 and 1.3 within 3 months of Screening using the extremity with the target ulcer.
Arterial Doppler ultrasound evaluating for biphasic or triphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of >0.75.
Disqualifiers
1. Ulceration with exposed tendon, capsule, or bone 2. IDSA-defined moderate or severe DFU infection. 3. Infected diabetic foot ulcer that is associated with local wound complication such as prosthetic materials or protruding surgical hardware.
Trial design
Treatments tested in this trial
- 5% Nu-3 gel
- 10% Nu-3 gel
- Placebo
Treatment groups
60 Participants
are divided into 5 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov