Diabetic Foot Ulcers

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide

267%

Cell Therapy

133%

+ 28 programs with unclassified modality

Competitive Landscape

24 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Integra LifeSciencesAustralia - Clayton

3 programs

DSC127Phase 31 trial

AMNIOEXCELN/ACell Therapy1 trial

Active Trials

NCT02209051Completed29Est. Aug 2015

NCT01830348Terminated266Est. Dec 2015

NCT01849965Terminated396Est. Dec 2015

Xequel BioSC - Mount Pleasant

2 programs

Granexin gelPhase 3

Granexin® gelPhase 1

BiocorpFrance - Issoire

2 programs

Granexin gelPhase 31 trial

Granexin® gelPhase 11 trial

Active Trials

NCT02652754Completed16Est. May 2018

NCT02667327Terminated124Est. May 2020

SanuwaveMN - Eden Prairie

2 programs

Electrohydraulic-generated shock wavePhase 31 trial

acoustical pulse energyPhase 31 trial

Active Trials

NCT01824407Unknown90

NCT00536744Completed206Est. Sep 2010

Abeona TherapeuticsCLEVELAND, OH

1 program

MSI-78Phase 32 trials

Active Trials

NCT00563394Completed584Est. Jul 1996

NCT00563433Completed342Est. Jul 1996

BioLightIsrael - Tel Aviv

1 program

Monochromatic phototherapy, Biolight®Phase 31 trial

Active Trials

NCT00859599Unknown107Est. Apr 2012

Protelight PharmaceuticalsChina - Jiangyin

1 program

Antimicrobial Peptide PL-5 Topical Spray and PlaceboPhase 2Peptide

Lynch BiologicsTN - Franklin

1 program

RhPDGF-BBPhase 21 trial

Active Trials

NCT03037970Unknown40Est. Oct 2017

AdociaFrance - Lyon

1 program

Biochaperone PDGF-BB Low dosePhase 1/21 trial

Active Trials

NCT01098357Completed192Est. Sep 2011

OmezaFL - Sarasota

1 program

Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectantPhase 11 trial

Active Trials

NCT05417425Completed25Est. Dec 2023

SolventumMN - St. Paul

3 programs

Moist Wound TherapyN/A1 trial

Powered Suction PumpN/A1 trial

V.A.C. Negative Pressure Wound Therapy SystemN/A1 trial

Active Trials

NCT00432965Completed335Est. Mar 2008

NCT00605189Terminated50Est. Nov 2010

NCT00847730Completed33Est. Sep 2009

StrykerCA - San Jose

1 program

APM GraftN/A1 trial

Active Trials

NCT01353495Completed39Est. Apr 2011

OrganogenesisCANTON, MA

1 program

Affinity AllograftN/A1 trial

Active Trials

NCT02880592Completed89Est. Apr 2019

Regenlab USANY - Brooklyn

1 program

Autologous platelet rich plasma gelN/A

LabcorpBURLINGTON, NC

1 program

Autologous platelet rich plasma gelN/A

Regen LabSwitzerland - Le Mont-sur-Lausanne

1 program

Autologous platelet rich plasma gelN/A1 trial

Active Trials

NCT02402374Unknown192Est. Dec 2020

ReapplixDenmark - Birkerød

1 program

LeucoPatch treatmentN/A1 trial

Active Trials

NCT01454401Completed60Est. Jan 2013

Oneness BiotechTaiwan - Taipei City

1 program

ON101 CreamN/A1 trial

Active Trials

NCT04945161Completed13Est. Dec 2021

RegenesisAZ - Scottsdale

1 program

The Provant Therapy SystemN/A

Regenesis BiomedicalAZ - Scottsdale

1 program

The Provant Therapy SystemN/A1 trial

Active Trials

NCT00761176Terminated8Est. Mar 2011

Baxter InternationalDEERFIELD, IL

1 program

Unite BiomatrixN/A1 trial

Active Trials

NCT00958711Terminated90Est. May 2012

BaxterCosta Rica - Cartago

1 program

Unite BiomatrixN/A

Karyopharm TherapeuticsNEWTON, MA

1 program

SelinexorPHASE_1_21 trial

Active Trials

NCT02367690Withdrawn0Est. Sep 2015

ParexelMA - Boston

1 program

Antimicrobial Peptide PL-5 Topical Spray and PlaceboPHASE_2Peptide1 trial

Active Trials

NCT06189638Active Not Recruiting90Est. Dec 2027

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

BiocorpGranexin gel

Integra LifeSciencesDSC127

SanuwaveElectrohydraulic-generated shock wave

Integra LifeSciencesDSC127

BioLightMonochromatic phototherapy, Biolight®

Sanuwaveacoustical pulse energy

Abeona TherapeuticsMSI-78

ParexelAntimicrobial Peptide PL-5 Topical Spray and Placebo

Lynch BiologicsRhPDGF-BB

Karyopharm TherapeuticsSelinexor

AdociaBiochaperone PDGF-BB Low dose

OmezaOmeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant

BiocorpGranexin® gel

Oneness BiotechON101 Cream

Showing 15 of 25 trials with date data

Clinical Trials (25)

Total enrollment: 3,416 patients across 25 trials

NCT02667327 BiocorpGranexin gel

A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer

Start: Nov 2018Est. completion: May 2020124 patients

Phase 3Terminated

NCT01849965 Integra LifeSciencesDSC127

Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers

Start: Apr 2013Est. completion: Dec 2015396 patients

Phase 3Terminated

NCT01824407 SanuwaveElectrohydraulic-generated shock wave

A Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers

Start: Mar 201390 patients

Phase 3Unknown

NCT01830348 Integra LifeSciencesDSC127

Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers

Start: Feb 2013Est. completion: Dec 2015266 patients

Phase 3Terminated

NCT00859599 BioLightMonochromatic phototherapy, Biolight®

Monochromatic Phototherapy on Diabetic Foot Ulcers

Start: Aug 2008Est. completion: Apr 2012107 patients

Phase 3Unknown

NCT00536744 Sanuwaveacoustical pulse energy

Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers

Start: Oct 2007Est. completion: Sep 2010206 patients

Phase 3Completed

NCT00563394 Abeona TherapeuticsMSI-78

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

Start: Aug 1994Est. completion: Jul 1996584 patients

Phase 3Completed

NCT00563433 Abeona TherapeuticsMSI-78

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

Start: Aug 1994Est. completion: Jul 1996342 patients

Phase 3Completed

NCT06189638 ParexelAntimicrobial Peptide PL-5 Topical Spray and Placebo

Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers

Start: Jan 2024Est. completion: Dec 202790 patients

Phase 2Active Not Recruiting

NCT03037970 Lynch BiologicsRhPDGF-BB

Evaluation of ABSOLVE in Diabetic Foot Ulcers

Start: Jan 2017Est. completion: Oct 201740 patients

Phase 2Unknown

NCT02367690 Karyopharm TherapeuticsSelinexor

Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) Patients

Start: Jan 2015Est. completion: Sep 20150

Phase 1/2Withdrawn

NCT01098357 AdociaBiochaperone PDGF-BB Low dose

Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer

Start: Jun 2010Est. completion: Sep 2011192 patients

Phase 1/2Completed

NCT05417425 OmezaOmeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant

Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers

Start: Sep 2022Est. completion: Dec 202325 patients

Phase 1Completed

NCT02652754 BiocorpGranexin® gel

Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers

Start: Sep 2015Est. completion: May 201816 patients

Phase 1Completed

NCT04945161 Oneness BiotechON101 Cream

A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs.

Start: Feb 2021Est. completion: Dec 202113 patients

N/ACompleted

NCT02402374 Regen LabAutologous platelet rich plasma gel

Evaluate the Safety and Efficacy of RegenKit Autologous PRP Gel for the Treatment of Diabetic Foot Ulcer

Start: Apr 2018Est. completion: Dec 2020192 patients

N/AUnknown

NCT02880592 OrganogenesisAffinity Allograft

Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers

Start: Aug 2016Est. completion: Apr 201989 patients

N/ACompleted

NCT02209051 Integra LifeSciencesAMNIOEXCEL

Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers

Start: Jul 2014Est. completion: Aug 201529 patients

N/ACompleted

NCT01454401 ReapplixLeucoPatch treatment

LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

Start: Oct 2010Est. completion: Jan 201360 patients

N/ACompleted

NCT01353495 StrykerAPM Graft

Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Start: Apr 2010Est. completion: Apr 201139 patients

N/ACompleted

NCT00847730 SolventumV.A.C. Negative Pressure Wound Therapy System

Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy

Start: Feb 2009Est. completion: Sep 200933 patients

N/ACompleted

NCT00958711 Baxter InternationalUnite Biomatrix

The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer

Start: Jan 2009Est. completion: May 201290 patients

N/ATerminated

NCT00761176 Regenesis BiomedicalThe Provant Therapy System

A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers

Start: Jul 2008Est. completion: Mar 20118 patients

N/ATerminated

NCT00605189 SolventumPowered Suction Pump

A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies

Start: Jul 2007Est. completion: Nov 201050 patients

N/ATerminated

NCT00432965 SolventumMoist Wound Therapy

Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers

Start: May 2002Est. completion: Mar 2008335 patients

N/ACompleted

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

8 late-stage (Phase 3) programs, potential near-term approvals

24 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.