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PluroGel N

Phase 2

Diabetic Foot Ulcer | Small molecule | Infectious Disease |cbdMD, Inc.|Last Updated: Sep 25, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

PluroGel N · 1 trial · 2 indications

Phase 2 1
NCT02091596Topical PluroGel N for the Treatment of Mildly Infected Diabetic Foot UlcersDiabetic Foot Ulcer
COMPLETED42 Analytics
PHASE2COMPLETED
Topical PluroGel N for the Treatment of Mildly Infected Diabetic Foot Ulcers
Diabetic Foot UlcerUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Response
14 Days

Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.

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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PluroGelPLACEBO_COMPARATORPluroGel
PluroGel NEXPERIMENTALPluroGel N

Interventions

NameTypeDescription
PluroGel NDRUGStudy Drug
PluroGelDRUGPluroGel Vehicle Placebo Comparator
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Non-hospitalized subjects with Type 1 or Type 2 diabetes mellitus as defined by the American Diabetes Association diagnostic criteria (ADA, 2010). Diabetes may be treated with insulin, oral hypoglycemic agents, diet, or a combination of these therapies. Subjects whose diabetes...

Countries:United States
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Frequently asked questions about PluroGel N

What is PluroGel N used for?

PluroGel N is an investigational small molecule being studied for the treatment of mildly infected diabetic foot ulcers. It is a topical gel developed by cbdMD, Inc. (YCBD) and is currently in Phase 2 clinical development.

What does PluroGel N target?

PluroGel N is a small molecule topical gel. Its specific molecular target has not been disclosed. It is being studied for its potential to treat mildly infected diabetic foot ulcers, a condition that involves both wound healing and infection control.

Who makes PluroGel N?

PluroGel N is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting clinical research to evaluate the gel's safety and efficacy for diabetic foot ulcers.

What phase is PluroGel N in?

PluroGel N is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.

What clinical trials is PluroGel N in?

PluroGel N has been studied in one completed Phase 2 clinical trial, NCT02091596, titled 'Topical PluroGel N for the Treatment of Mildly Infected Diabetic Foot Ulcers.' This randomized, double-blind, placebo-controlled trial enrolled 42 participants in the United States.

Is PluroGel N the same as any other drug?

PluroGel N is the name used in clinical trials for this investigational topical gel. No alternative names have been reported for this drug candidate.