Ingestion of bioactive collagen hydrolysates enhanced pressure ulcer healing in a randomized double-blind placebo-controlled clinical study

Abstract

We conducted a double blind, multi-centric, placebo-controlled, randomized trial to compare the Pressure Ulcer Scale for Healing (PUSH) and Pressure Sore Status Tool (PSST) scores and wound area measurements at 16 weeks of subjects with pressure ulcers who were given standard care plus one of two types of collagen hydrolysate (CH-a), which contained low levels of prolylhydroxyproline (Pro-Hyp) and hydroxyprolylglycine (Hyp-Gly), and CH-b, which contained high levels of Pro-Hyp and Hyp-Gly) with the placebo group. A total of 120 subjects with stage II or III pressure ulcers were entered into the trial and 112 subjects completed the study. The subjects were randomized to receive CH-a (n = 39), CH-b (n = 39), or a placebo (n = 42) twice daily (10 g per day) for 16 weeks. The PUSH score, PSST score, and wound area of the CH-b group were significantly lower than the placebo group at week 16 (PUSH score, P < 0.001; PSST score, P < 0.01; wound area, P < 0.05). The PUSH score of the CH-a group was significantly lower than the placebo group at week 16 (P < 0.05). This study demonstrated that CH-b ingestion helps healing of pressure ulcers as an add-on to the standard therapy.

Figure 1

Flow chart of the study design and the passage of the subjects through it. After enrollment, 122 subjects were randomized into three arms, the CH-a, CH-b, and placebo groups. Thirty-eight subjects in the CH-a group, 35 subjects in the CH-b group, and 39 subjects in the placebo group completed the study. *One subject each from the CH-a and CH-b groups, who did not satisfy the test criteria as they dropped out before any post-baseline data had been obtained, were replaced with two further subjects, who were then subjected to randomization.

Figure 2

Comparisons of the primary treatment efficacy parameters (the Pressure Ulcer Scale for Healing (PUSH) score (A), Pressure Sore Status Tool (PSST) score (B), and wound area (C)) between the baseline and week 16. Data are expressed as mean values (N = 38, 35, and 39 for the CH-a, CH-b and placebo groups, respectively). The PUSH and PSST scores and the pressure ulcer surface area of the CH-b group were significantly lower than those of the placebo group at week 16 (PUSH score, P < 0.01; PSST score, P = 0.01; wound area, P = 0.027). The PUSH score of the CH-a group was significantly lower than that of the placebo group at week 16 (P = 0.029).