Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in diabetic patients with critical limb ischemia with no possibility of revascularization: study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial)

Table 1 Schedule of study procedures

	Study period
	Enrolment		Treatment	Follow-up
Timepoint	*V-1, selection visit*	*V0, baseline visit*	V1, treatment	*V2, 24 h*	*V3, 3 m*	*V4, 6 m*	*V5, 12 m*
Timepoint	*Day − 30 to day − 21*	*Day − 20 to − 1*	Day 0	*Day 1*	*Day + 90 ± 7*	*Day + 180 ± 15*	*Day + 365 ± 15*
*Eligibility criteria*	X	X
*Informed consent*	X
*Anamnesis*	X
*Physical examination*	X		X	X	X	X	X
*Blood test*	X				X	X	X
*Urine pregnancy test*	X
*Rutherford-Becker category*	X
*Ankle-arm index*	X				X	X	X
*Ulcers evaluation (Wifi classification)*	X				X	X	X
*VAS scale*	X			X	X	X	X
*Gastrocnemius muscle perimeter*	X				X	X	X
*Temperature of the limb*	X				X	X	X
*Neuropathic symptoms*	X				X	X	X
*Quality of life scales (SF-12 and VascuQol-6)*	X				X	X	X
*MRI*	X						X
*Randomization*		X
*Pre surgical evaluation*		X
*Treatment administration*			X
*Concomitant medication*	X	X	X		X	X	X
*Adverse events*			X	X	X	X	X

ISSN: 1745-6215