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Diabetic Foot Ulcer

22
Pipeline Programs
30
Companies
50
Clinical Trials
11 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 41 trial
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
+1 more trials
Serena Group
Serena GroupMA - Cambridge
3 programs
2
Activate™ MatrixPhase 41 trial
Tri-Membrane Wrap™ DFUPhase 41 trial
Dual-layer perinatal tissue allograftN/A1 trial
Active Trials
NCT06437028Recruiting170Est. Sep 2026
NCT07086443Recruiting350Est. Jul 2027
NCT07364630Recruiting50Est. Jan 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 4
Integra LifeSciences
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
1 program
1
ADRCsPhase 31 trial
Active Trials
NCT05095389Unknown290Est. Jul 2025
Energenesis Biomedical
Energenesis BiomedicalTaiwan - Taipei
1 program
1
ENERGI-F703 GELPhase 31 trial
Active Trials
NCT05930210Recruiting230Est. Mar 2026
Oneness Biotech
2 programs
1
Xianglei Tangzu GaoPhase 2/31 trial
ON101 CreamN/A1 trial
Active Trials
NCT05135130Completed160Est. Jan 2022
NCT06531512Recruiting120Est. Mar 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
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
Transwell BiotechTaiwan - Hsinchu
1 program
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
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
1 program
APIC-PRPN/A1 trial
Active Trials
NCT02209662Unknown274Est. Dec 2015
Nanordica Medical
Nanordica MedicalEstonia - Tallinn
1 program
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
Serena GroupTri-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: 5,759 patients across 50 trials

NCT07364630Serena GroupTri-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: Mar 2026120 patients
Phase 2/3Recruiting
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
NCT06578650Acera SurgicalElectrospun Fiber Matrix

A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms

Start: Oct 2024Est. completion: May 202734 patients
N/ARecruiting
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/ANot Yet Recruiting
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

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
11 actively recruiting trials targeting 5,759 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.