Ann: Update - SynPath Diabetic Foot Ulcer Trial, page-12

I also think that. The paragraph exclusively talks about an expected delay to completion of enrolment and then states they are going to make "an amendment" to the protocol (as in one change)

https://clinicaltrials.gov/ct2/show/NCT05506215

Brief Summary:
The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment.
Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment

	Condition or disease	Intervention/treatment	Phase
1	Diabetic Foot Chronic Foot Ulcer Wound Healing Foot Ulcer	Device: SynPath Acellular Dermal Matrix plus Off-loading Device Device: Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device	Not Applicable

mce-anchor
mce-anchorDetailed Description:
One hundred and thirty-eight (138) subjects with chronic Diabetic Foot Ulcers ranging in size from 1cm2 to 25cm2 will be randomized 1:1 to either SynPath™ or Standard of Care after the completion of a 14 day screening/run-in period. Following the of run-in period the subjects with a 'hard to heal' or chronic, (>4 weeks) nonresponsive Wagner Grade 1 or 2 diabetic foot ulcer will be randomized to receive either SynPath™ or SOC treatment. Both treatment groups will require subjects to use off-loading device.
mce-anchorStudy Design

Go to

	Study Type :	Interventional (Clinical Trial)
1	Estimated Enrollment :	138 participants
2	Allocation:	Randomized
3	Intervention Model:	Parallel Assignment
4	Masking:	None (Open Label)
5	Primary Purpose:	Treatment
6	Official Title:	A Prospective, Multicenter, Open Label, Randomized, Controlled Clinical Study Evaluating the Effect of NovoSorb ® SynPath™ Dermal Matrix Compared to Standard of Care (SOC) In the Treatment of Nonresponsive, Chronic Diabetic Foot Ulcers.
7	Actual Study Start Date :	July 10, 2022
8	Estimated Primary Completion Date :	June 1, 2023
9	Estimated Study Completion Date :	October 1, 2023