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NCT05930210 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer

A Phase 3 study of Diabetes Mellitus and Diabetic Foot Ulcer, sponsored by Energenesis Biomedical Co..

Recruiting
Registry status
Phase 3
Development phase
230
Enrollment target
20
Study locations

NCT05930210 is a Phase 3 study of Diabetes Mellitus and Diabetic Foot Ulcer that is actively recruiting participants, run by Energenesis Biomedical Co.. The registered enrollment target is 230 participants, below the 1,866-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT05930210, a Phase 3 study of Diabetes Mellitus and Diabetic Foot Ulcer, is actively recruiting participants, sponsored by Energenesis Biomedical Co..

RECRUITING
Registry status
Phase 3
Development phase
230 participants
Enrollment target
20
Study locations

Study Summary

This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers. Baseline target ulcer size (\<16 cm2 vs ≥16 cm2 ) will be included as a stratification factor. Subjects will be randomized 1:1 to receive ENERGI-F703 GEL or vehicle control using an interactive web response system for randomization to automatically assign a unique subject randomization number. Total duration of the study will be up to 31 weeks including Screening visit (approximately 2 to 3 weeks), double-blind dosing/observation phase (16 weeks), and a safety follow-up of 12 weeks after the last administration of study treatment.

Interventions

  • DRUG ENERGI-F703 GEL
  • DRUG ENERGI-F703 matched vehicle

Study Locations (20)

Other

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital - Chiayi City
  • Kaohsiung Medical University Hospital - Kaohsiung City
  • China Medical University Hospital - Taichung
  • Kung Tien General Hospital - Taichung
  • Taichung Veterans General Hospital - Taichung
  • Chi Mei Medical Center - Tainan
  • National Cheng Kung University Hospital - Tainan
  • Cathay General Hospital - Taipei
  • MacKay Memorial Hospital - Taipei
  • National Taiwan University Hospital - Taipei

Florida

  • A and D Doctor Center - Miami
  • Bioclinical Research - Miami
  • Reliant Medical Research - Miami
  • Advanced Medical Research Institute - Miami
  • New Horizons Research - Palmetto Bay

Georgia

  • IACT Health - Columbus

Tennessee

  • The Jackson Clinic PA - Jackson

Texas

  • Mt. Olympus Medical Research - Houston

Utah

  • Wasatch Clinical Research - Salt Lake City

Virginia

  • Salem Veterans Affairs Medical Center VAMC - Salem

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2023-05-30
Est. Completion 2026-03-31
Phase Phase 3

Sponsor

Energenesis Biomedical Co.

1 total trials

What the Registry Record Tells You About NCT05930210

The ClinicalTrials.gov registry entry for NCT05930210 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,866-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (88% lower). The listed sponsor is Energenesis Biomedical Co., which has 1 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which ENERGI-F703 GEL is the first listed.

NCT05930210 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT05930210 about?

NCT05930210 is a clinical study titled "A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer". This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers. Baseline target ulcer size (\<16 cm2 vs ≥16 cm2 ) wi...

What is the current status of trial NCT05930210?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2023-05-30. Estimated completion is 2026-03-31.

What conditions does trial NCT05930210 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Diabetic Foot Ulcer, Foot Ulcer, Wound.

What interventions are being tested in trial NCT05930210?

The interventions under investigation include: ENERGI-F703 GEL (DRUG), ENERGI-F703 matched vehicle (DRUG).

Who is sponsoring clinical trial NCT05930210?

This trial is sponsored by Energenesis Biomedical Co., which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05930210 being conducted?

This trial has 20 study locations across Florida, Georgia, Tennessee, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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