PMID- 17244316
OWN - NLM
STAT- MEDLINE
DCOM- 20070605
LR  - 20161124
IS  - 1067-1927 (Print)
IS  - 1067-1927 (Linking)
VI  - 15
IP  - 1
DP  - 2007 Jan-Feb
TI  - Thrombin peptide Chrysalin stimulates healing of diabetic foot ulcers in a 
      placebo-controlled phase I/II study.
PG  - 23-34
AB  - Thrombin and thrombin peptides play a role in initiating tissue repair. The 
      potential safety and efficacy of TP508 (Chrysalin) treatment of diabetic foot 
      ulcers was evaluated in a 60-subject, prospective, randomized, double-blind, 
      placebo-controlled phase I/II clinical trial. Chrysalin in saline or saline alone 
      was applied topically, twice weekly, to diabetic ulcers with standardized care 
      and offloading. A dose-dependent effect was seen in the per-protocol population 
      where 1 and 10 mug Chrysalin treatment resulted in 45 and 72% more subjects with 
      complete healing than placebo treatment. Chrysalin treatment of foot ulcers more 
      than doubled the incidence of complete healing (p<0.05), increased mean closure 
      rate approximately 80% (p<0.05), and decreased the median time to 100% closure by 
      approximately 40% (p<0.05). Chrysalin treatment of heel ulcers within this 
      population resulted in mean closure rates 165% higher than placebos (p<0.02) and 
      complete healing in 86% (6/7) of ulcers compared with 0% (0/5) of placebo ulcers 
      (p<0.03). Local wound reactions and adverse events (AEs) were equal between 
      groups with no reported drug-related changes in laboratory tests or serious AEs. 
      These results indicate the potential safety and efficacy of Chrysalin for 
      treatment of diabetic foot ulcers.
FAU - Fife, Caroline
AU  - Fife C
AD  - Department of Anesthesiology, University of Texas Health Science Center, Houston, 
      Texas 77555-0645, USA.
FAU - Mader, Jon T
AU  - Mader JT
FAU - Stone, Jeffery
AU  - Stone J
FAU - Brill, Leon
AU  - Brill L
FAU - Satterfield, Kathleen
AU  - Satterfield K
FAU - Norfleet, Andrea
AU  - Norfleet A
FAU - Zwernemann, Amber
AU  - Zwernemann A
FAU - Ryaby, James T
AU  - Ryaby JT
FAU - Carney, Darrell H
AU  - Carney DH
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Wound Repair Regen
JT  - Wound repair and regeneration : official publication of the Wound Healing Society 
      [and] the European Tissue Repair Society
JID - 9310939
RN  - 0 (Peptide Fragments)
RN  - 9J556O9JPD (rusalatide acetate)
RN  - EC 3.4.21.5 (Thrombin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Diabetic Foot/*drug therapy/pathology
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Peptide Fragments/*administration & dosage
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Thrombin/*administration & dosage
MH  - Treatment Outcome
MH  - Wound Healing/*drug effects
EDAT- 2007/01/25 09:00
MHDA- 2007/06/06 09:00
CRDT- 2007/01/25 09:00
PHST- 2007/01/25 09:00 [pubmed]
PHST- 2007/06/06 09:00 [medline]
PHST- 2007/01/25 09:00 [entrez]
AID - WRR181 [pii]
AID - 10.1111/j.1524-475X.2006.00181.x [doi]
PST - ppublish
SO  - Wound Repair Regen. 2007 Jan-Feb;15(1):23-34. doi: 
      10.1111/j.1524-475X.2006.00181.x.