An interventional study of Hēlaquis Matrix is a hyaluronic acid matrix (HaM) in Diabetic Foot, sponsored by SerenaGroup, Inc.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by SerenaGroup, Inc. · Not applicable, Interventional, and Treatment
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.
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.
The Screening Phase consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria, treatment.
At the Screening Visit (SV), written informed consent is obtained from the subject by the Investigator or designee prior to the performance of any other protocol-specific procedure.
At the SV, the Investigator will select the Index (study) ulcer. Each subject will have only one DFU selected as the Index (study) ulcer. If the subject has more than one ulcer at the SV, the Investigator will select the largest ulcer that meets the eligibility criteria of the protocol as the Index (study) ulcer.
The SV is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study. Those subjects who meet the eligibility criteria may transition to Treatment Visit 1 (TV1) on the same day as the SV or at a later date.
The Treatment Phase (12 Weeks) Subjects who meet eligibility criteria at the SV will receive HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period.
During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using digital photographic planimetry. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subjects may receive up to eight applications of HaM. Subjects whose study ulcer does not heal after eight applications will receive only SOC treatment for 4 additional weeks. Subjects whose ulcers do not achieve closure at or by 12 weeks or who experience an amputation will be deemed treatment failures.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →SerenaGroup, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive weekly application of Ham along with standard of care therapy for eight (8) weeks unless healing occurs prior to 8 weeks.
Device: Hēlaquis Matrix is a hyaluronic acid matrix (HaM)
Hēlaquis Matrix is a hyaluronic acid matrix (HaM) derived from the American Alligator and indicated for the treatment of chronic wounds. Hyaluronic Acid (HA) is a naturally occurring non sulphated glycosaminoglycan consisting of a linear sequence of D-glucuronic and N -acetyl-Dglucosamine. It is present in connective tissue and plays a role in several biological processes including tissue repair.
Evaluate Wound healing in Wagner 1 and 2 grade DFUs by wound size
To evaluate the effectiveness of HaM as an adjunctive treatment in facilitating complete wound healing in Wagner 1 and 2 grade DFUs when compared to well-established standard of care healing rates
Time frame: 12 weeks
Evaluate Wound healing by wound closure
Proportion of wounds healed at 12 weeks
Time frame: 12 weeks
Evaluate wound healing by surface area reduction of greater than 40%
Proportion of wounds with surface area reduction of greater than 40% at 4 weeks
Time frame: 4 weeks
Occurrence of adverse events through case report forms
Incidence of adverse events
Time frame: 12 weeks
Bacterial burden measured by Imaging
The effect of HaM on bacterial burden as measured by fluorescence imaging using the MolecuLight device
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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SerenaGroup, Inc.