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DGD

Phase 3

Burn | Small molecule | Dermatology |MediWound Ltd.|Last Updated: Sep 9, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment218

FDA Designations

No designations recorded

Clinical trial landscape

DGD · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00324311Enzymatic Debridement in Burns Patients: A Comparison to Standard of CareBurn
COMPLETED182 Analytics
PHASE3COMPLETED
Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care
BurnUnlock trial analytics

Study Endpoints

Primary Endpoints

Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds
Surgical excision/dermabrasion performed as initial debridement (surgical SOC group) or as first post-debridement procedure (DGD or non-surgical SOC groups)
Co-primary: % treated wound autografted of deep partial wounds
Post-debridement autografts
The primary endpoint is safety as measured by: 1. Systemic an local adverse events, 2. Changes in vital signs and laboratory tests, 3. Time to wound closure.
Throughout the study

Secondary Endpoints

% treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds
As for primary endpoint
Time to complete wound closure
% epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed
Timely eschar removal
Debridement procedures
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DGDEXPERIMENTAL -
SOCACTIVE_COMPARATOR -

Interventions

NameTypeDescription
DGDDRUGLyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
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Eligibility Criteria

Age Range4 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: 1. Males and females between 4 years to 55 years of age, 2. Thermal burns caused by fire/flame, scalds or contact, 3. Deep partial thickness (mixed deep dermal) and/or full thickness (3°) burn wounds ≥ 5% and ≤ 30% Total Body Surface Area (TBSA); all these wounds must receive st...

Countries:AustraliaBrazilFranceGermanyIsraelItalyPolandRomaniaSlovakiaUnited KingdomIndia
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Frequently asked questions about DGD

What is DGD used for?

DGD is an investigational small molecule used for enzymatic debridement in patients with burns. It is being developed to remove dead or damaged tissue from burn wounds as part of the standard of care. The drug is still in clinical development and has not been approved by regulatory authorities.

Who makes DGD?

DGD is being developed by MediWound Ltd., a biopharmaceutical company traded on the Nasdaq under the ticker MDWD. The company is conducting clinical trials to evaluate the safety and efficacy of DGD for burn debridement.

What phase is DGD in?

DGD is in Phase 3 clinical development for burn debridement. A Phase 3 study has been completed, along with an earlier Phase 2 feasibility study. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is DGD in?

DGD has been studied in two completed clinical trials. The Phase 3 trial NCT00324311 enrolled 182 patients with burns across multiple countries, comparing enzymatic debridement to standard of care. The Phase 2 trial NCT00898521 enrolled 36 patients with partial thickness burns in India and Israel.

Is DGD the same as NexoBrid?

DGD is also known as NexoBrid, a name used for the same investigational enzymatic debridement agent. Both names refer to the product being developed by MediWound Ltd. for the treatment of burn wounds.