Who is sponsoring NCT05198544?

NCT05198544 is sponsored by SerenaGroup, Inc..

What drugs are being tested in NCT05198544?

Interventions in NCT05198544: Hēlaquis Matrix is a hyaluronic acid matrix (HaM).

What condition does NCT05198544 study?

NCT05198544 studies Diabetic Foot.

Is NCT05198544 still recruiting?

NCT05198544 is currently status unknown. Last updated 26 April 2023.

Last reviewed 2023-04-26 · How we verify

NCT05198544

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Trial Evaluating a Hyaluronic Acid Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs)

Status unknown NA Last updated 26 April 2023

What this trial tests

NA trial testing Hēlaquis Matrix is a hyaluronic acid matrix (HaM) in Diabetic Foot in 15 participants. Status unknown.

Timeline

1 June 2023

Primary endpoint
1 December 2023

31 December 2023

Quick facts

Lead sponsor	SerenaGroup, Inc.
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 June 2023
Primary completion	1 December 2023
Estimated completion	31 December 2023

Drugs / interventions tested

Hēlaquis Matrix is a hyaluronic acid matrix (HaM)

Conditions studied

Diabetic Foot — all drugs for Diabetic Foot →

Sponsor

SerenaGroup, Inc. — full company profile →

Who can join

18 and older, any sex, with Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs. After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period. The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Innovative Functional Biomaterials as Therapeutic Wound Dressings for Chronic Diabetic Foot Ulcers.
Da Silva J, Leal EC, Carvalho E, Silva EA. · · 2023 · cited 27× · PMID 37373045 · DOI 10.3390/ijms24129900

Verify or expand the search:

Other recruiting trials for Diabetic Foot

Currently open trials in the same condition.

NCT06487780 — Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers · NA · recruiting
NCT06674980 — Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DF · NA · recruiting
NCT06760416 — Online Diabetic Foot Support Program- Care Kit · NA · active not recruiting
NCT06552910 — Analyzing Anesthetic Techniques in Diabetic Foot Amputation · recruiting
NCT06526936 — The Effect of Foot Care Training Given to Diabetic Hemodialysis Patients on Foot Care Behavior · NA · recruiting

Other SerenaGroup, Inc. trials

Trials by the same sponsor.

NCT05107050 — Comparing a Synergistic Antimicrobial Cleanser and Gel to Normal Saline and an Amorphous Gel in Reducing Bioburden and P · NA · unknown
NCT05033470 — A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers · NA · unknown
NCT04888624 — A Comparison Between Two Post-operative Dressings · NA · completed
NCT05076578 — A Prospective Clinical Study Evaluating the Harvesting of Micografts · NA · completed
NCT04332003 — Evaluating Remote Ischemic Conditioning (RIC) and Standard of Care vs. Sham Therapy and Standard Care · NA · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05198544 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SerenaGroup, Inc.
Last refreshed: 26 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05198544.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing