Diabetic Foot Ulcer

8
Pipeline Programs
11
Companies
19
Clinical Trials
1 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
3
1
2
1
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

11 companies ranked by most advanced pipeline stage

AVITA Medical
AVITA MedicalCA - Valencia
1 program
1
ReGenerCell™ Autologous Cell Harvesting DevicePhase 41 trial
Active Trials
NCT02799121Completed16Est. Mar 2019
Organogenesis
OrganogenesisCANTON, MA
5 programs
2
DermagraftPhase 31 trial
DermagraftPhase 31 trial
Affinity human amniotic membraneN/A1 trial
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy SystemN/A1 trial
NuShieldN/A1 trial
Active Trials
NCT03205436CompletedEst. Aug 2019
NCT01623882WithdrawnEst. Dec 2015
NCT03855514UnknownEst. Dec 2021
+2 more trials
Pfizer
PfizerNEW YORK, NY
1 program
1
FragminPhase 2/31 trial
Active Trials
NCT00765063Completed62Est. Oct 2010
Aurealis Therapeutics
Aurealis TherapeuticsSwitzerland - Zug
2 programs
1
1
AUP1602-CPhase 21 trial
AUP1602-CPhase 1/21 trial
Active Trials
NCT04281992CompletedEst. Mar 2023
NCT06111183CompletedEst. Nov 2025
KB
Kuros BiosciencesSwitzerland - Schlieren
1 program
1
Good Standard of CarePhase 21 trial
Active Trials
NCT00915486CompletedEst. Mar 2012
RION
RIONMN - Rochester
1 program
1
PEPPhase 21 trial
Active Trials
NCT06319287CompletedEst. Nov 2025
ConvaTec
ConvaTecNJ - Bridgewater
2 programs
Avelle NPWTN/A1 trial
InnovaMatrix AC porcine placental ECM therapyN/A1 trial
Active Trials
NCT05666570WithdrawnEst. Mar 2023
NCT05687656Active Not RecruitingEst. 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
Kerecis
KerecisIceland - Isafjordur
2 programs
Kerecis Omega3 WoundN/A1 trial
Kerecis™ Omega3 WoundN/A1 trial
Active Trials
NCT04133493Active Not RecruitingEst. Jan 2023
NCT04257370CompletedEst. Nov 2022
Nanordica Medical
Nanordica MedicalEstonia - Tallinn
1 program
Advanced Antibacterial Wound DressingN/A1 trial
Active Trials
NCT06667752RecruitingEst. Jun 2026
Podimetrics
PodimetricsMA - Somerville
1 program
Podimetrics SmartMatN/A1 trial
Active Trials
NCT05968924CompletedEst. Apr 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AVITA MedicalReGenerCell™ Autologous Cell Harvesting Device
OrganogenesisDermagraft
OrganogenesisDermagraft
PfizerFragmin
RIONPEP
Aurealis TherapeuticsAUP1602-C
Kuros BiosciencesGood Standard of Care
Aurealis TherapeuticsAUP1602-C
Nanordica MedicalAdvanced Antibacterial Wound Dressing
BioStem TechnologiesBR-AC
PodimetricsPodimetrics SmartMat
BioStem TechnologiesVendaje
ConvaTecInnovaMatrix AC porcine placental ECM therapy
ConvaTecAvelle NPWT
KerecisKerecis™ Omega3 Wound

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 249 patients across 19 trials

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

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

Start: Dec 1998Est. completion: Mar 2000
Phase 3Completed

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

Start: Sep 1994Est. completion: Jan 1997
Phase 3Completed

The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

Start: Oct 2008Est. completion: Oct 201062 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 2025
Phase 2Completed

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

Start: Jul 2023Est. completion: Nov 2025
Phase 2Completed
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 2012
Phase 2Completed

Treatment of Diabetic Foot Ulcers With AUP1602-C

Start: Jan 2020Est. completion: Mar 2023
Phase 1/2Completed
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 2026
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
NCT05968924PodimetricsPodimetrics SmartMat

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

Start: Jul 2024Est. completion: Apr 2025
N/ACompleted

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

Start: Jan 2024Est. completion: Jun 2025100 patients
N/AUnknown
NCT05687656ConvaTecInnovaMatrix AC porcine placental ECM therapy

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

Start: Oct 2022Est. completion: Dec 2025
N/AActive Not Recruiting

The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

Start: May 2022Est. completion: Mar 2023
N/AWithdrawn
NCT04257370KerecisKerecis™ Omega3 Wound

Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations

Start: Jul 2020Est. completion: Nov 2022
N/ACompleted
NCT04133493KerecisKerecis Omega3 Wound

Omega3 Wound Fish Skin Graft in the Treatment of DFUs

Start: Jul 2019Est. completion: Jan 2023
N/AActive Not Recruiting

Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers

Start: Feb 2019Est. completion: Dec 2021
N/AUnknown
NCT03205436OrganogenesisAffinity human amniotic membrane

Affinity Prospective Diabetic Foot Trial Crossover Group

Start: May 2017Est. completion: Aug 2019
N/ACompleted
NCT01623882OrganogenesisClinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System

Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System

Start: Jun 2012Est. completion: Dec 2015
N/AWithdrawn

Phase Legend

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

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 249 patients
11 companies competing in this space