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Diabetic Foot Ulcer (DFU)

3
Pipeline Programs
7
Companies
6
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
0
0
0
2
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Royal Biologics
Royal BiologicsNJ - Hackensack
1 program
1
Amnio-Maxx® Dual Layer Amnion PatchPhase 41 trial
Active Trials
NCT07209475Recruiting248Est. Aug 2026
Oneness Biotech
Oneness BiotechTaiwan - Taipei City
1 program
1
Fespixon CreamPhase 41 trial
Active Trials
NCT05438251Terminated3Est. Apr 2024
Aposcience
AposcienceAustria - Vienna
1 program
1
APO-2Phase 1/21 trial
Active Trials
NCT04277598Completed159Est. Dec 2023
Tides Medical
Tides MedicalLA - Lafayette
1 program
AllograftN/A1 trial
Active Trials
NCT06681428Recruiting240Est. Nov 2026
Biolab Pharma
Biolab PharmaBrazil - São Paulo
1 program
IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane WrapN/A1 trial
Active Trials
NCT07046767Recruiting165Est. Jul 2026
Serena Group
Serena GroupMA - Cambridge
1 program
OneStep Foot ScannerN/A1 trial
Active Trials
NCT06782386Active Not Recruiting100Est. Aug 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Royal BiologicsAmnio-Maxx® Dual Layer Amnion Patch
Oneness BiotechFespixon Cream
AposcienceAPO-2
Biolab PharmaIP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap
Serena GroupOneStep Foot Scanner
Tides MedicalAllograft

Clinical Trials (6)

Total enrollment: 915 patients across 6 trials

NCT07209475Royal BiologicsAmnio-Maxx® Dual Layer Amnion Patch

Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.

Start: Aug 2025Est. completion: Aug 2026248 patients
Phase 4Recruiting
NCT05438251Oneness BiotechFespixon Cream

Exploring the Effect of Fespixon Cream for the Treatment of Diabetic Foot Ulcers (TEXAS 3A, 3B)

Start: Aug 2022Est. completion: Apr 20243 patients
Phase 4Terminated
NCT04277598AposcienceAPO-2

A Study to Evaluate Safety and Efficacy of APO-2 at Three Different Doses in Patients With Diabetic Foot Ulcer

Start: Oct 2020Est. completion: Dec 2023159 patients
Phase 1/2Completed
NCT07046767Biolab PharmaIP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap

CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations

Start: Oct 2025Est. completion: Jul 2026165 patients
N/ARecruiting
NCT06782386Serena GroupOneStep Foot Scanner

Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers

Start: Feb 2025Est. completion: Aug 2026100 patients
N/AActive Not Recruiting
NCT06681428Tides MedicalAllograft

Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers

Start: Nov 2024Est. completion: Nov 2026240 patients
N/ARecruiting

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 actively recruiting trials targeting 915 patients
7 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.