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Diabetic Foot Ulcer

22
Pipeline Programs
30
Companies
50
Clinical Trials
9 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
5
2
2
6
5
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

47 companies ranked by most advanced pipeline stage

Acera Surgical
Acera SurgicalMO - St. Louis
4 programs
1
Electrospun Fiber MatrixPhase 4
Restrata TM Wound MatrixN/A1 trial
Restrata®N/A1 trial
Synthetic Hybrid-Scale Fiber MatrixN/A1 trial
Active Trials
NCT03312595Completed30Est. Jul 2018
NCT04918784Completed46Est. Dec 2022
NCT04927702Terminated48Est. Aug 2024
Serena Group
Serena GroupMA - Cambridge
3 programs
2
Activate™ MatrixPhase 41 trial
Tri-Membrane Wrap™ DFUPhase 4
Dual-layer perinatal tissue allograftN/A1 trial
Active Trials
NCT06437028Recruiting170Est. Sep 2026
NCT07086443Recruiting350Est. Jul 2027
AVITA Medical
AVITA MedicalCA - Valencia
1 program
1
ReGenerCell™ Autologous Cell Harvesting DevicePhase 41 trial
Active Trials
NCT02799121Completed16Est. Mar 2019
Biolab Pharma
1 program
1
Tri-Membrane Wrap™ DFUPhase 41 trial
Active Trials
NCT07364630Recruiting50Est. Jan 2027
Integra LifeSciences
Integra LifeSciencesAustralia - Clayton
7 programs
1
0.03% DSC127 topical gelPhase 31 trial
AMNIOEXCEL Plus Amniotic MembraneN/A1 trial
Amnio Excel + weeklyN/A1 trial
AmnioExcel Plus Amniotic MembraneN/A1 trial
Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic TissueN/A1 trial
+2 more programs
Active Trials
NCT03547635Completed116Est. Feb 2019
NCT04233580Completed40Est. Apr 2021
NCT05024656Withdrawn0Est. Jun 2024
+4 more trials
NovaLead Pharma
2 programs
1
1
Esmolol HydrochloridePhase 31 trial
Esmolol hydrochloridePhase 1/21 trial
Active Trials
NCT01113515Completed44Est. Oct 2015
NCT03998436Completed176Est. Dec 2021
Adocia
2 programs
2
BioChaperone PDGF-BBPhase 31 trial
platelet-derived growth factor BB (BioChaperone formulation)Phase 3
Active Trials
NCT02236793Completed252Est. Aug 2016
Paracrine
ParacrineCA - San Diego
1 program
1
ADRCsPhase 31 trial
Active Trials
NCT05095389Unknown290Est. Jul 2025
Energenesis Biomedical
1
ENERGI-F703 GELPhase 31 trial
Active Trials
NCT05930210Recruiting230Est. Mar 2026
Oneness Biotech
Oneness BiotechTaiwan - Taipei City
2 programs
1
Xianglei Tangzu GaoPhase 2/31 trial
ON101 CreamN/A1 trial
Active Trials
NCT05135130Completed160Est. Jan 2022
NCT06531512Active Not Recruiting120Est. Aug 2026
Pfizer
PfizerNEW YORK, NY
1 program
1
Fragmin/ Dalteparin SodiumPhase 2/31 trial
Active Trials
NCT00662831Completed276Est. Oct 2010
Aurealis Therapeutics
Aurealis TherapeuticsSwitzerland - Zug
1 program
1
AUP1602-CPhase 22 trials
Active Trials
NCT06111183Completed64Est. Nov 2025
NCT04281992Completed26Est. Mar 2023
Angeles Therapeutics
1
Offloading BootPhase 21 trial
Active Trials
NCT04460573Recruiting210Est. Mar 2026
Biomed
1 program
1
A hydrogel containing erythropoietinPhase 1/21 trial
Active Trials
NCT02361931Completed20Est. Jun 2018
SaNOtize
SaNOtizeBC - Vancouver
1 program
1
Nitric Oxide-Releasing SolutionPhase 1/21 trial
Active Trials
NCT04755647Completed40Est. May 2023
TechnoPhage
1 program
1
TP-102Phase 1/21 trial
Active Trials
NCT04803708Completed20Est. Sep 2022
Transwell Biotech
1
TWB-103Phase 1/21 trial
Active Trials
NCT03624023Completed10Est. Jul 2021
Cynata Therapeutics
1
CYP-006TKPhase 11 trial
Active Trials
NCT05165628Completed30Est. Sep 2024
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
1
CorlicytePhase 11 trial
Active Trials
NCT04104451Completed16Est. Aug 2023
Organogenesis
OrganogenesisCANTON, MA
5 programs
Affinity human amniotic membraneN/A1 trial
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy SystemN/A
NuShieldN/A1 trial
DermagraftPHASE_31 trial
DermagraftPHASE_31 trial
Active Trials
NCT03205436Completed20Est. Aug 2019
NCT03855514Unknown200Est. Dec 2021
NCT01181440Completed281Est. Jan 1997
+1 more trials
ConvaTec
ConvaTecNJ - Bridgewater
2 programs
Avelle NPWTN/A1 trial
InnovaMatrix AC porcine placental ECM therapyN/A1 trial
Active Trials
NCT05666570Withdrawn0Est. Mar 2023
NCT05687656Active Not Recruiting30Est. Dec 2025
BioStem Technologies
BioStem TechnologiesPOMPANO BEACH, FL
2 programs
BR-ACN/A1 trial
VendajeN/A1 trial
Active Trials
NCT06511596Completed71Est. Dec 2025
NCT06150209Unknown100Est. Jun 2025
Primex Pharmaceuticals
Primex PharmaceuticalsSwitzerland - Zug
2 programs
ChitoCare gelN/A1 trial
ChitoCare medical Wound Healing GelN/A1 trial
Active Trials
NCT04178525Terminated46Est. Sep 2020
NCT05570877Completed92Est. Oct 2024
Kerecis
2 programs
Kerecis Omega3 WoundN/A1 trial
Kerecis™ Omega3 WoundN/A1 trial
Active Trials
NCT04133493Active Not Recruiting100Est. Jan 2023
NCT04257370Completed260Est. Nov 2022
ETS
ETSMO - Rolla
2 programs
Mirragen Advanced Wound MatrixN/A1 trial
OffloadingN/A1 trial
Active Trials
NCT06403605Completed148Est. Jan 2025
NCT03398538Completed40Est. Oct 2018
Reapplix
1 program
3C PatchN/A1 trial
Active Trials
NCT03997526Terminated22Est. Feb 2022
Arch Therapeutics
AC5N/A2 trials
Active Trials
NCT06028386Unknown60Est. Aug 2024
NCT02704104Completed46Est. Jun 2016
Cytonics
CytonicsFL - Jupiter
1 program
APIC-PRPN/A1 trial
Active Trials
NCT02209662Unknown274Est. Dec 2015
Nanordica Medical
Advanced Antibacterial Wound DressingN/A1 trial
Active Trials
NCT06667752Recruiting170Est. Jun 2026
Labcorp
LabcorpBURLINGTON, NC
1 program
Bioresorbable 3D electrospun synthetic matrixN/A1 trial
Active Trials
NCT04437537Completed11Est. Jul 2025

+17 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Biolab PharmaTri-Membrane Wrap™ DFU
Serena GroupActivate™ Matrix
AVITA MedicalReGenerCell™ Autologous Cell Harvesting Device
Energenesis BiomedicalENERGI-F703 GEL
ParacrineADRCs
NovaLead PharmaEsmolol Hydrochloride
Integra LifeSciences0.03% DSC127 topical gel
AdociaBioChaperone PDGF-BB
OrganogenesisDermagraft
OrganogenesisDermagraft
Oneness BiotechXianglei Tangzu Gao
PfizerFragmin/ Dalteparin Sodium
RIONPEP
Aurealis TherapeuticsAUP1602-C
Angeles TherapeuticsOffloading Boot

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 6,025 patients across 50 trials

NCT07364630Biolab PharmaTri-Membrane Wrap™ DFU

A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.

Start: Jan 2026Est. completion: Jan 202750 patients
Phase 4Recruiting
NCT07086443Serena GroupActivate™ Matrix

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

Start: Jul 2025Est. completion: Jul 2027350 patients
Phase 4Recruiting
NCT02799121AVITA MedicalReGenerCell™ Autologous Cell Harvesting Device

A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers

Start: May 2016Est. completion: Mar 201916 patients
Phase 4Completed

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

Start: May 2023Est. completion: Mar 2026230 patients
Phase 3Recruiting

Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers

Start: Feb 2023Est. completion: Jul 2025290 patients
Phase 3Unknown
NCT03998436NovaLead PharmaEsmolol Hydrochloride

Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers

Start: Dec 2018Est. completion: Dec 2021176 patients
Phase 3Completed
NCT01840085Integra LifeSciences0.03% DSC127 topical gel

Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use

Start: Dec 2015Est. completion: Dec 2015261 patients
Phase 3Terminated
NCT02236793AdociaBioChaperone PDGF-BB

A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer

Start: Dec 2014Est. completion: Aug 2016252 patients
Phase 3Completed

Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers

Start: Dec 1998Est. completion: Mar 2000314 patients
Phase 3Completed

Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers

Start: Sep 1994Est. completion: Jan 1997281 patients
Phase 3Completed
NCT06531512Oneness BiotechXianglei Tangzu Gao

Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers

Start: Aug 2024Est. completion: Aug 2026120 patients
Phase 2/3Active Not Recruiting
NCT00662831PfizerFragmin/ Dalteparin Sodium

Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients

Start: Apr 2008Est. completion: Oct 2010276 patients
Phase 2/3Completed

Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)

Start: Feb 2024Est. completion: Nov 202559 patients
Phase 2Completed

Evaluation of AUP12602-C as New Topical Treatment for DFUs (DIAMEND STUDY)

Start: Jul 2023Est. completion: Nov 202564 patients
Phase 2Completed

Smart Boot Use to Measure Offloading Adherence

Start: Oct 2021Est. completion: Mar 2026210 patients
Phase 2Recruiting
NCT00915486Kuros BiosciencesGood Standard of Care

A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers

Start: May 2009Est. completion: Mar 2012211 patients
Phase 2Completed

Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

Start: Mar 2021Est. completion: Sep 202220 patients
Phase 1/2Completed
NCT04755647SaNOtizeNitric Oxide-Releasing Solution

Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers

Start: Feb 2021Est. completion: May 202340 patients
Phase 1/2Completed

Treatment of Diabetic Foot Ulcers With AUP1602-C

Start: Jan 2020Est. completion: Mar 202326 patients
Phase 1/2Completed

TWB-103 for Treating Lower Limb Ulcers on Patients With DM

Start: Dec 2019Est. completion: Jul 202110 patients
Phase 1/2Completed
NCT02361931BiomedA hydrogel containing erythropoietin

Topical Erythropoietin Hydrogel Formulation for Diabetic Foot Ulcers

Start: Mar 2016Est. completion: Jun 201820 patients
Phase 1/2Completed
NCT01113515NovaLead PharmaEsmolol hydrochloride

Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers

Start: Feb 2014Est. completion: Oct 201544 patients
Phase 1/2Completed

Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers

Start: Jan 2022Est. completion: Sep 202430 patients
Phase 1Completed

PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS

Start: Nov 2019Est. completion: Aug 202316 patients
Phase 1Completed
NCT07465640Defence TherapeuticsPulsating electromagnetic field

Evaluating the Efficacy of Pulsating Electromagnetic Field Therapy by CRAD ULCER X-01 for Diabetic Foot Ulcers

Start: Mar 2026Est. completion: Apr 202732 patients
N/ANot Yet Recruiting
NCT07161830OmezaOmeza® Complete Matrix

Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers

Start: Dec 2025Est. completion: Mar 2027130 patients
N/ARecruiting
NCT06437028Serena GroupDual-layer perinatal tissue allograft

Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.

Start: May 2025Est. completion: Sep 2026170 patients
N/ARecruiting
NCT04437537LabcorpBioresorbable 3D electrospun synthetic matrix

Pilot Study of PHOENIX Wound Matrix® Impact on Chronic DFU Wound Microbiome

Start: Mar 2025Est. completion: Jul 202511 patients
N/ACompleted
NCT06453187Integra LifeSciencesUrinary Bladder Matrix

A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

Start: Nov 2024Est. completion: Mar 2027350 patients
N/AEnrolling By Invitation
NCT06667752Nanordica MedicalAdvanced Antibacterial Wound Dressing

Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer

Start: Oct 2024Est. completion: Jun 2026170 patients
N/ARecruiting

Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care

Start: Sep 2024Est. completion: Aug 2025124 patients
N/ARecruiting

A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC

Start: Sep 2024Est. completion: Dec 202571 patients
N/ACompleted

A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix

Start: Sep 2024Est. completion: May 202585 patients
N/AUnknown
NCT06557122EncollSOC and Advanced Bioengineered Skin Substitute

Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers

Start: Jul 2024Est. completion: Oct 202424 patients
N/ACompleted
NCT05968924PodimetricsPodimetrics SmartMat

Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology

Start: Jul 2024Est. completion: Apr 202520 patients
N/ACompleted

Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC

Start: Jun 2024Est. completion: Sep 2027180 patients
N/ARecruiting

A Controlled Prospective Treatment Study to Evaluate the Efficacy of Vendaje.

Start: Jan 2024Est. completion: Jun 2025100 patients
N/AUnknown

Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers

Start: Aug 2023Est. completion: Aug 202460 patients
N/AUnknown

Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

Start: Jun 2023Est. completion: Nov 2025143 patients
N/ACompleted
NCT05687656ConvaTecInnovaMatrix AC porcine placental ECM therapy

Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers

Start: Oct 2022Est. completion: Dec 202530 patients
N/AActive Not Recruiting
NCT06403605ETSMirragen Advanced Wound Matrix

Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

Start: Sep 2022Est. completion: Jan 2025148 patients
N/ACompleted

The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

Start: May 2022Est. completion: Mar 20230
N/AWithdrawn
NCT05570877Primex PharmaceuticalsChitoCare medical Wound Healing Gel

ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds

Start: Jan 2022Est. completion: Oct 202492 patients
N/ACompleted
NCT04210609VaporoxVaporous Hyperoxia Therapy

Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers

Start: Oct 2021Est. completion: Oct 202230 patients
N/AUnknown

Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer

Start: Oct 2021Est. completion: Jan 2022160 patients
N/ACompleted
NCT05024656Integra LifeSciencesAmnioExcel Plus Amniotic Membrane

AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers

Start: Sep 2021Est. completion: Jun 20240
N/AWithdrawn
NCT05046158Enterprise TherapeuticsTransforming Powder Dressing

Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Start: Aug 2021Est. completion: Nov 2025135 patients
N/ACompleted
NCT04927702Acera SurgicalSynthetic Hybrid-Scale Fiber Matrix

Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)

Start: Jul 2021Est. completion: Aug 202448 patients
N/ATerminated

Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers

Start: May 2021Est. completion: Dec 202246 patients
N/ACompleted
NCT03960255ViiV HealthcareNormal standard care

Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers

Start: Feb 2021Est. completion: May 2023300 patients
N/AUnknown

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

6 late-stage (Phase 3) programs, potential near-term approvals
9 actively recruiting trials targeting 6,025 patients
30 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.